capecitabine / Generic mfg. - LARVOL DELTA

Induction Paclitaxel-Cisplatin-Capecitabine for Nasopharyngeal Carcinoma. (PubMed, NEJM Evid) - P3 | "Among patients with high-risk LA-NPC, TPC induction chemotherapy was associated with higher 5-year FFS than PF. (Funded by National Natural Science Foundation of China and State Key Laboratory of Respiratory Disease; ClinicalTrials.gov number, NCT02940925.)."

Clinical • Journal • Epstein-Barr Virus Infections • Nasopharyngeal Carcinoma • Oncology • Respiratory Diseases • Solid Tumor

Four Months of Adjuvant XELOX versus Six Months in Stage II–IIIB Gastric Cancer — The LOMAC Randomized Trial (ESMO 2026) - No abstract available

Clinical • Late-breaking abstract • Gastric Cancer • Oncology • Solid Tumor

Quality of Life and 5-Year Long-Term Organ Preservation in Early Rectal Adenocarcinoma Final Results from the OPERA Trial (ASTRO 2025) - "Patients received external beam radiotherapy (EBRT) with concurrent capecitabine, with randomization to receive either EBRT boost (9 Gy/5 fractions) or CXB boost (90 Gy/3 fractions)... The OPERA trial demonstrated that CXB boost significantly improves long-term OP in early rectal cancer with comparable QoL outcomes between EBRT and CXB groups. While CXB led to higher incidence of mild rectal bleeding initially, this resolved over time. These results emphasize the importance of maintaining close patient surveillance in the first 5 years."

Clinical • HEOR • Colorectal Adenocarcinoma • Colorectal Cancer • Oncology • Rectal Adenocarcinoma • Solid Tumor

Zanidatamab + chemotherapy (CT) ± tislelizumab for first-line (1L) HER2-positive (HER2+) locally advanced, unresectable, or metastatic gastroesophageal adenocarcinoma (mGEA): Primary analysis from HERIZON-GEA-01. (ASCO-GI 2026) - P3 | "Background: HERIZON-GEA-01 (NCT05152147) is a global, open-label, phase 3 trial of zanidatamab (dual HER2-targeted bispecific antibody) + CT ± tislelizumab (anti–PD-1) vs trastuzumab (tras) + CT in 1L HER2+ mGEA. Eligible patients (pts) with previously untreated HER2+ mGEA, regardless of PD-L1 status, were randomized (1:1:1) to zanidatamab (1800 mg [12 mo) vs tras + CT. Zanidatamab + tislelizumab + CT also provided a statistically significant and clinically meaningful OS benefit (mOS >26 mo). The trial is ongoing with additional OS analyses planned for zanidatamab + CT."

Clinical • Late-breaking abstract • Metastases • Esophageal Adenocarcinoma • Esophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor • HER-2

Datopotamab deruxtecan versus chemotherapy in previously treated inoperable/metastatic hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer: results from the TROPION-Breast01 China cohort. (PubMed, ESMO Open) - "In this China cohort, Dato-DXd demonstrated numerically improved efficacy versus ICC and a manageable safety profile, consistent with the global population, supporting Dato-DXd as a new treatment option for Chinese patients with previously treated metastatic HR+/HER2- breast cancer."

Journal • Breast Cancer • Dental Disorders • Hematological Disorders • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Mucositis • Neutropenia • Oncology • Solid Tumor • Stomatitis • HER-2

Node-sparing modified short-course radiotherapy combined with CAPOX and tislelizumab versus conventional short-course preoperative chemoradiotherapy for proficient mismatch repair or microsatellite stable locally advanced rectal cancer (mRCAT-III): A multicenter, randomized, open-label, phase 3 trial. (ASCO 2026) - P3 | "Following randomization, patients will receive short-course radiotherapy (conventional or node-sparing) followed by four cycles of CAPOX ± tislelizumab: tislelizumab 200 mg IV on day 1, oxaliplatin 130 mg/m² IV on day 1, and capecitabine 1000 mg/m² orally on days 1-14, and Total mesorectal excision (TME) will be performed at weeks 14-15. Compared with conventional short-course preoperative chemoradiotherapy, node-sparing modified radiotherapy combined with CAPOX and PD-1 blockade significantly improved pCR rates in patients with pMMR/MSS LARC, with a manageable safety profile. This regimen represents a promising and highly effective neoadjuvant strategy for MSS rectal cancer. Clinical trial information: NCT06507371."

Clinical • Late-breaking abstract • Metastases • Mismatch repair • P3 data • pMMR • Colorectal Cancer • Oncology • Rectal Cancer • Solid Tumor

Rationale 305: Phase 3 study of tislelizumab plus chemotherapy vs placebo plus chemotherapy as first-line treatment (1L) of advanced gastric or gastroesophageal junction adenocarcinoma (GC/GEJC). (ASCO-GI 2023) - P3 | " Adults with previously untreated, unresectable locally advanced or metastatic GC/GEJC, regardless of PD-L1 expression, were randomized (1:1) to receive TIS (200 mg IV Q3W) plus ICC (oxaliplatin [130 mg/m² IV Q3W] and oral capecitabine [1,000 mg/m² BID, Days 1-14 Q3W] or cisplatin [80 mg/m² IV Q3W] and 5-fluorouracil [800 mg/m²/day IV, Days 1-5 Q3W]) or P+ICC. In RATIONALE 305, TIS+ICC provided significant and clinically meaningful improvement in OS vs P+ICC with well acceptable safety as 1L in PD-L1+ patients with advanced GC/GEJC. These data suggest this combination is a new 1L option for this patient population. Clinical trial information: NCT03777657."

Clinical • IO biomarker • Metastases • P3 data • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor • HER-2 • PD-L1

Node-sparing modified short-course Radiotherapy Combined with CAPOX and Tislelizumab for locally Advanced MSS of Middle and low rectal Cancer (mRCAT): an open-label, single-arm, prospective, multicentre clinical trial. (PubMed, BMC Cancer) - P2 | "In our research, node-sparing modified radiotherapy combined with immunotherapy probably increased the responsiveness of immunotherapy for MSS/pMMR rectal cancer patients, reduced the occurrence of postoperative rectal fibrosis, and improved survival and quality of life. This is the first clinical trial to utilize a node-sparing radiation strategy combined with chemotherapy and PD-1 blockade in the neoadjuvant treatment of rectal cancer, which may result in a breakthrough in the treatment of MSS/pMMR rectal cancer."

Clinical protocol • Journal • Metastases • Colorectal Cancer • Fibrosis • Gastrointestinal Cancer • Hematological Malignancies • Immunology • Oncology • Rectal Cancer • Solid Tumor • CD8

DKN-01 in Combination With Tislelizumab and Chemotherapy as First-Line Therapy in Advanced Gastric or Gastroesophageal Junction Adenocarcinoma: DisTinGuish. (PubMed, J Clin Oncol) - P2 | "DKN-01 can be safely combined with frontline fluoropyrimidine/oxaliplatin and tislelizumab and demonstrates encouraging activity independent of PD-L1 expression levels. A randomized phase II trial is ongoing (ClinicalTrials.gov identifier: NCT04363801)."

Combination therapy • IO biomarker • Journal • Metastases • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor • DKK1 • HER-2 • PD-L1

Tislelizumab (TIS) plus chemotherapy (CT) vs placebo (PBO) plus CT in HER2-negative advanced or metastatic gastric or gastro-esophageal junction adenocarcinoma (GC/GEJC): PD-L1 biomarker analysis from RATIONALE-305 (ESMO-GI 2024) - P3 | "Here we report exploratory analyses of OS subgroup results by PD-L1 expression status and concordance between PD-L1 TAP score and combined positive score (CPS). Adults with GC/GEJC were randomized (1:1) to IV TIS 200 mg or PBO every 3 weeks + investigator-chosen CT (oxaliplatin + capecitabine or cisplatin + 5-fluorouracil). The addition of TIS to CT as 1L treatment for GC/GEJC improved OS in pts with PD-L1 TAP ≥10% and ≥1%. These data, with prior data from pts with PD-L1 TAP ≥5% and all randomized pts, support TIS + CT as a new 1L treatment option for advanced HER2-negative GC/GEJC. Concordant TAP and CPS results suggest both methods are viable for clinical PD-L1 expression measurement in pts with GC/GEJC."

Biomarker • Clinical • IO biomarker • Metastases • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • HER-2 • PD-L1

Perioperative tislelizumab plus chemotherapy versus chemotherapy in MHC-II positive/MHC-II negative locally advanced GC/GEJC: A prospective, randomized, open-label, biomarker-driven, phase 2 trial. (ASCO 2026) - P2 | "For experimental group, patients received either 3 preoperative and 3 postoperative cycles of tislelizumab plus SOX/XELOX, followed by 11 cycles of tislelizumab. In conclusion, compared with perioperative chemotherapy alone, the addition of tislelizumab to a given chemotherapy regimen significantly increased the proportion of mPR and pCR in tsMHC-II-positive patients with GAC/GEJAC only, which revealed that tsMHC-II could be a biomarker to guide the selection of appropriate GAC/GEJAC patients for perioperative immunotherapy."

Biomarker • Clinical • IO biomarker • Metastases • P2 data • Gastric Cancer

First-line tislelizumab (TIS) plus chemotherapy (CT) vs placebo (PBO) plus CT in advanced/metastatic esophageal squamous cell carcinoma (ESCC): A post-hoc analysis of different investigator-choice CT and tumor PD-L1 expression level subgroups in RATIONALE-306 (ESMO 2025) - P3 | "Background In the global phase 3 RATIONALE-306 study, random assignment to TIS or PBO was stratified by investigator-choice CT of platinum (cisplatin or oxaliplatin) with 5-FU (fluoropyrimidine or capecitabine) (FP) vs. platinum with paclitaxel (TP), enabling an unbiased analysis of TIS efficacy vs. PBO with these regimens...These findings offer potential insights into selecting CT regimens based on PD-L1 status. Further validation in future studies is needed."

Biomarker • Clinical • IO biomarker • Metastases • Retrospective data • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Oncology • Squamous Cell Carcinoma • PD-L1

Neoadjuvant Chemoradiotherapy Followed by Chemotherapy With or Without Tislelizumab for Resectable Ultra-low Rectal Cancer: The RELIEVE-02 Study (clinicaltrials.gov) - P3 | N=196 | Recruiting | Sponsor: Fudan University | Not yet recruiting ➔ Recruiting

Enrollment open • Colorectal Cancer • Oncology • Rectal Adenocarcinoma • Rectal Cancer • Solid Tumor • MLH1 • MSH2 • MSH6 • MSI

Adjuvant tislelizumab, lenvatinib, and capecitabine for resected biliary tract cancer: a prospective phase II trial. (PubMed, BMC Med) - P2 | "Adjuvant tislelizumab, lenvatinib, and capecitabine demonstrated clinical activity and tolerable safety in patients with resected BTC. Despite not meeting the primary endpoint, continued follow-up and further evaluation are warranted to better define the potential role of this combination regimen."

Journal • P2 data • Biliary Cancer • Biliary Tract Cancer • Cholangiocarcinoma • Oncology • Solid Tumor • FSIP2

Tislelizumab (Tisle) combined with POFI (irinotecan, paclitaxel, oxaliplatin and 5-FU/levoleucovorin) as first-line treatment of advanced gastric/gastroesophageal junction adenocarcinoma (AGC): OS analysis results of the SYLT-023. (ASCO-GI 2025) - P1/2 | "The combination of Tisle + XELOX/FP is a first-line treatment of AGC in China... Tisle+POFI was well tolerated and showed preliminary antitumor activity in AGC. A phase II study is ongoing."

Clinical • Metastases • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor • HER-2 • PD-L1

Tislelizumab plus chemotherapy versus placebo plus chemotherapy as first line treatment for advanced gastric or gastro-oesophageal junction adenocarcinoma: RATIONALE-305 randomised, double blind, phase 3 trial. (PubMed, BMJ) - P3 | "Tislelizumab added to chemotherapy as primary treatment for advanced or metastatic gastric or gastro-oesophageal junction adenocarcinoma provided superior overall survival with a manageable safety profile versus placebo plus chemotherapy in patients with a PD-L1 TAP score of ≥5%, and in all randomised patients."

Clinical • IO biomarker • Journal • Metastases • P3 data • P3 data • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • HER-2

Zanidatamab + chemotherapy (CT) ± tislelizumab for first-line (1L) HER2-positive (HER2+) locally advanced or metastatic gastroesophageal adenocarcinoma (mGEA): PD-L1 subgroup analysis from HERIZON-GEA-01. (ASCO 2026) - P3 | " Eligible patients (pts) with previously untreated HER2+ mGEA, irrespective of PD-L1 status, were randomized (1:1:1) to zanidatamab (1800 mg [<70 kg]/2400 mg [≥70 kg] IV Q3W) + tislelizumab (200 mg IV Q3W) + capecitabine/oxaliplatin (CAPOX) or 5-FU/cisplatin (FP); zanidatamab + CAPOX or FP; or tras + CAPOX or FP... In HERIZON-GEA-01, zanidatamab + tislelizumab + CT demonstrated meaningful improvements in PFS and OS in both PD-L1–positive and PD-L1–negative pts as determined by TAP or CPS. The longer OS observed with tras + CT in PD-L1–positive vs –negative pts may be at least partially explained by differences in subsequent therapies. These findings are notable as they demonstrate benefit for this regimen regardless of PD-L1 status."

Clinical • IO biomarker • Metastases • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor • HER-2 • PD-L1

Efficacy and Safety of Neoadjuvant GEMOX Chemotherapy Combined with Lenvatinib and Tislelizumab in Patients with Resectable Biliary Tract Malignancies at High Risk of Recurrence (ChiCTR) - P2 | N=30 | Not yet recruiting | Sponsor: Ningbo Medical Centre Lihuili Hospital; Ningbo Medical Centre Lihuili Hospital

New P2 trial • Biliary Cancer • Biliary Tract Cancer • Cholangiocarcinoma • Gallbladder Cancer • Oncology • Solid Tumor

Tislelizumab versus XELOX as adjuvant therapy for high-risk (T4/N+) MSI-H/dMMR colon cancer: Safety, efficacy, and immune microenvironment profiling in a randomized phase II trial (KSMO 2026) - No abstract available

Clinical • dMMR • MSI-H • P2 data • Colon Cancer • Colorectal Cancer • Microsatellite Instability • Oncology • Solid Tumor • MSI

Node-sparing modified short-course radiotherapy combined with CAPOX and tislelizumab versus conventional short-course preoperative chemoradiotherapy for proficient mismatch repair or microsatellite stable locally advanced rectal cancer (mRCAT-III): A multicenter, randomized, open-label, phase 3 trial. (ASCO 2025) - P3 | "Following randomization, patients will receive short-course radiotherapy (conventional or node-sparing) followed by four cycles of CAPOX ± tislelizumab: tislelizumab 200 mg IV on day 1, oxaliplatin 130 mg/m² IV on day 1, and capecitabine 1000 mg/m² orally on days 1-14, and Total mesorectal excision (TME) will be performed at weeks 14-15. The Data Monitoring Committee (DMC) reviewed the trial in December 2024 and recommended continuing as planned. Clinical trial information: NCT06507371."

Clinical • Metastases • Mismatch repair • P3 data • pMMR • Colorectal Cancer • Oncology • Rectal Cancer • Solid Tumor

CapeOx Combined With Anti-PD1 Antibody Plus Dihydroartemisinin as Neoadjuvant or Conversion Therapy for Microsatellite Stable Locally Advanced and Metastatic Colorectal Cancer (clinicaltrials.gov) - P2 | N=15 | Active, not recruiting | Sponsor: Shanghai Changzheng Hospital

New P2 trial • Colorectal Cancer • Oncology • Solid Tumor

Short-Course Radiotherapy-Based Total Neoadjuvant Therapy plus Tislelizumab for Locally Advanced Rectal Cancer (Neo-STAR): Early Outcomes of a Randomized Phase II Trial. (PubMed, Cancer Commun (Lond)) - P2 | "This phase II randomized clinical trial aimed to evaluate the efficacy and safety of SCRT followed by capecitabine plus oxaliplatin (CAPOX) and tislelizumab versus SCRT followed by CAPOX alone in LARC. This phase II study provides preliminary evidence of promising tumor regression with SCRT-TNT combined with tislelizumab in LARC, warranting further validation in phase III trials. Trial registration: This trial was registered at clinicaltrials.gov (Identifier: NCT05086627)."

Clinical • Journal • P2 data • Colorectal Adenocarcinoma • Colorectal Cancer • Hematological Disorders • Oncology • Rectal Adenocarcinoma • Rectal Cancer • Solid Tumor

Tislelizumab (Tisle) combined with POFI (irinotecan, paclitaxel, oxaliplatin, and 5-FU/levoleucovorin) as first-line treatment for advanced gastric/gastroesophageal junction adenocarcinoma (AGC): Update from a single-arm, open-label phase I/II trial (SYLT-023). (ASCO 2026) - P1/2 | "The combination of Tisle + XELOX/FP is a first-line treatment of AGC in China... Tisle + POFI showed promising efficacy and a manageable safety profile as first-line treatment for HER2-negative, pMMR/MSS AGC, warranting further investigation."

Clinical • Metastases • P1/2 data • Gastric Adenocarcinoma • Gastroesophageal Junction Adenocarcinoma • Hematological Disorders • Leukopenia • Neutropenia • Oncology • Solid Tumor • HER-2 • PD-L1

Tislelizumab plus chemotherapy versus placebo plus chemotherapy as first-line treatment for advanced or metastatic oesophageal squamous cell carcinoma (RATIONALE-306): a global, randomised, placebo-controlled, phase 3 study. (PubMed, Lancet Oncol) - P3 | "Tislelizumab plus chemotherapy as a first-line treatment for advanced or metastatic oesophageal squamous cell carcinoma provided superior overall survival with a manageable safety profile versus placebo plus chemotherapy. Given that the interim analysis met its superiority boundary for the primary endpoint, as confirmed by the independent data monitoring committee, this Article represents the primary study analysis."

IO biomarker • Journal • Metastases • P3 data • Cardiovascular • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Gastrointestinal Disorder • Hematological Disorders • Infectious Disease • Oncology • Pneumonia • Pulmonary Disease • Respiratory Diseases • Septic Shock • Solid Tumor • Squamous Cell Carcinoma • Tuberculosis • PD-L1

Characterization and management of gastrointestinal (GI) adverse events (AEs) with zanidatamab + chemotherapy (CT) ± tislelizumab in first-line (1L) HER2-positive (HER2+) locally advanced or metastatic gastroesophageal adenocarcinoma (mGEA): Analysis from HERIZON-GEA-01. (ASCO 2026) - P3 | "Funded by Jazz Pharmaceuticals, BeOne Medicines, Zymeworks Biopharmaceuticals Clinical Trial Registration Number: NCT05152147 Background: In HERIZON-GEA-01, replacing 1L trastuzumab (tras) + CT with zanidatamab + CT ± tislelizumab significantly improved progression-free survival and, with tislelizumab, yielded a statistically significant overall survival benefit in HER2+ mGEA... Eligible patients (pts) with previously untreated HER2+ mGEA were randomized 1:1:1 to zanidatamab (1800 mg [<70 kg]/2400 mg [≥70 kg] IV Q3W) + tislelizumab (200 mg IV Q3W) + capecitabine/oxaliplatin (CAPOX) or 5-FU/cisplatin (FP); zanidatamab + CAPOX or FP; or tras + CAPOX or FP... In zanidatamab-treated pts, most diarrhea events were grade 1/2, and first-onset events tended to occur in cycle 1 and resolved in <3 wk. Diarrhea rarely led to zanidatamab discontinuation. The safety of zanidatamab-containing regimens appears favorable given the survival benefits; diarrhea should be..."

Adverse events • Clinical • Metastases • Gastroenterology • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Disorder • Immunology • Oncology • Solid Tumor • HER-2