Tyvyt (sintilimab) / Innovent Biologics, Eli Lilly, Mankind Pharma - LARVOL DELTA

K-NADIR: Fulzerasib Sequential Sintilimab Plus Platinum-Doublet Neoadjuvant Therapy for Resectable KRAS G12C-Mutant NSCLC (clinicaltrials.gov) - P2 | N=30 | Recruiting | Sponsor: Jianxing He

New P2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • KRAS

CP-IVX001: Study of Intratumoral IVX037 in Patients With Advanced or Metastatic Solid Tumours (clinicaltrials.gov) - P1 | N=70 | Recruiting | Sponsor: ImmVirx Pty Ltd | Trial completion date: Nov 2026 ➔ Nov 2028 | Trial primary completion date: Sep 2026 ➔ Jun 2028

Trial completion date • Trial primary completion date • Colorectal Cancer • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Cancer • Gastroesophageal Cancer • Oncology • Ovarian Cancer • Solid Tumor • MSI

The Efficacy and Safety of the Combination of PD-1 With Chemotherapy and Adaptive Radiotherapy Strategy in the Treatment of Stage III Non-small Cell Lung Cancer Patients (clinicaltrials.gov) - P2 | N=35 | Recruiting | Sponsor: The Third Xiangya Hospital of Central South University | Not yet recruiting ➔ Recruiting

Enrollment open • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • HER-2 • ROS1

A Clinical Study of Sintilimab Combined With Chemothrapy Versus Chemotherapy as Adjuvant Therapy for Gastric/Gastroesophageal Junction Adenocarcinoma (clinicaltrials.gov) - P2 | N=276 | Recruiting | Sponsor: Fudan University

dMMR • MSI-H • New P2 trial • Esophageal Cancer • Gastric Adenocarcinoma • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Microsatellite Instability • Oncology • Solid Tumor • MSI

Sintilimab plus anlotinib in later-line treatment of advanced KRAS-mutant NSCLC: a multicenter, retrospective case series. (PubMed, Front Med (Lausanne)) - "This real-world case series suggests that sintilimab plus anlotinib offers promising efficacy and manageable toxicity as a later-line, chemotherapy-free regimen for advanced KRAS-mutant NSCLC. The absence of prior anti-angiogenic therapy emerged as a strong positive predictor for survival, underscoring the importance of strategic treatment sequencing in clinical practice."

IO biomarker • Journal • Retrospective data • Cardiovascular • Dermatology • Hypertension • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • KRAS

Efficacy and safety of first-line immunotherapy and targeted therapy in advanced HCC: a network meta-analysis with subgroup analysis based on HBV and HCV infection. (PubMed, Front Immunol) - "In the overall population, regimens with significant OS advantage over sorafenib included sintilimab plus bevacizumab biosimilar (HR = 0.57, 95% CrI 0.43-0.75), camrelizumab plus rivoceranib (HR = 0.62, 0.48-0.79), and atezolizumab plus bevacizumab (HR = 0.66, 0.51-0.84). For PFS, top-ranked combinations were camrelizumab plus rivoceranib (HR = 0.52, 0.41-0.66), anlotinib plus penpulimab (HR = 0.53, 0.41-0.68), lenvatinib plus pembrolizumab (HR = 0.55, 0.44-0.68), and sintilimab plus bevacizumab biosimilar (HR = 0.56, 0.45-0.69)...Regarding safety, tislelizumab (RR = 0.42, 0.33-0.52) and nivolumab (RR = 0.45, 0.36-0.56) were associated with the lowest incidence of AEs≥3...In non-viral HCC, the STRIDE regimen (single priming dose tremelimumab plus durvalumab) was the only regimen to significantly improve OS (HR = 0.75, 0.59-0.96)...This etiology-stratified evidence..."

Clinical • Journal • Retrospective data • Review • Hepatitis C • Hepatocellular Cancer • Infectious Disease • Oncology • Solid Tumor

Efficacy and safety of sintilimab combined with anlotinib in relapsed and refractory small cell lung cancer: A phase II clinical trial (ELCC 2026) - P2 | "No unexpected immune-related AEs were observed.Conclusions The combination of sintilimab with anlotinib showed encouraging efficacy and manageable toxicity in relapsed and refractory SCLC patients with ≤6-month CTFI. Further evaluation is ongoing."

Clinical • P2 data • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Unclear territory: navigating metastatic nonclear cell renal cell carcinoma. (PubMed, Curr Opin Oncol) - "Therapeutic advances are reshaping the management of nccRCC, with IO/TKI regimens and histology-specific therapies showing promise. Continued integration of molecular classification, rare subtype-specific trials, and international collaboration will be essential to establish evidence-based treatment standards for this diverse and understudied population."

Journal • Genito-urinary Cancer • Kidney Medullary Carcinoma • Non Clear Cell Renal Cell Carcinoma • Oncology • Papillary Renal Cell Carcinoma • Renal Cell Carcinoma • Solid Tumor • ALK • FH

Randomized trial of relevance of time-of-day of immunochemotherapy for progression-free and overall survival in patients with non-small cell lung cancer. (ASCO 2025) - P3 | " Eligible pts received ICI pembrolizumab or sintilimab combined with chemotherapy, as 1st line treatment for stage IIIC-IV NSCLC without driver mutation. In this randomized trial, all three efficacy endpoints of immunochemotherapy were significantly improved through Early vs Late ToD dosing in pts with previously untreated stage IIIC-IV NSCLC. The near doubling in PFS and OS in our trial support the need for further randomized trials to determine the relevance of ToD for ICI efficacy and their underlying circadian mechanisms in pts with various cancer types."

Clinical • IO biomarker • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

Fruquintinib (FRUQ) plus sintilimab (SIN) versus axitinib (AXI) or everolimus (EVE) monotherapy as 2L treatment in pts with locally advanced or metastatic renal cell carcinoma (RCC): Results from phase III part of a randomized, open-label, active-controlled phase II/III study (FRUSICA-2) (ESMO 2025) - P2/3 | "The incidences of grade ≥3 TEAEs (71.4% vs 58.8%), TEAEs leading to treatment discontinuation (17.6% vs 9.6%), and fatal TEAEs (4.2% vs 4.4%) were comparable between groups. Table: 2592MO Efficacy Results by IMDC Prognostic Risk ITT set (BIRC-assessed) IMDC risk factor Number of IMDC risk factor Favorable-risk Intermediate-risk Poor-risk 0-1 risk factors FRUQ+ SIN N=33 AXI/EVE N=32 FRUQ+ SIN N=73 AXI/EVE N=72 FRUQ+ SIN N=13 AXI/EVE N=11 FRUQ+ SIN N=76 AXI/EVE N=73 mPFS, months NR 8.31 22.21 6.97 9.69 4.21 24.87 8.31 Unstratified HR (95% CI) 0.270 (0.117, 0.620) 0.352 (0.221, 0.562) 0.591 (0.203, 1.721) 0.278 (0.168, 0.461) Unstratified log-rank p * 0.0009 <0.0001 0.3267 <0.0001 ORR (%) 63.6 25.0 61.6 23.6 46.2 27.3 63.2 26.0 Odds ratio (95% CI) 5.250 (1.608, 17.712) 5.200 (2.394, 11.435) 2.286 (0.315, 19.098) 4.872 (2.292, 10.456) p * 0.0019 <0.0001 0.3514 <0.0001 *Two-sided Conclusions FRUQ+SIN demonstrated superior mPFS and manageable safety compared..."

Clinical • Metastases • Monotherapy • P2/3 data • P3 data • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

Bringing immunotherapy to clinical practice in dMMR/MSI-high colon cancer. (PubMed, Cancer Cell) - "showed that dual anti-CTLA-4/PD-1 IBI310/sintilimab for 6 weeks improved pathological complete response over sintilimab in patients with cT4/N+ tumors. This combination represents a referral regimen for neoadjuvant or organ-preserving strategies."

dMMR • Journal • MSI-H • Colon Cancer • Colorectal Cancer • Oncology • Solid Tumor

Fruquintinib monotherapy as second-line (2L) treatment in locally advanced or metastatic renal cell carcinoma (RCC): Results from phase II part of FRUSICA-2 (ESMO Asia 2025) - P2/3 | "Background: FRUSICA-2 is a randomized, open-label, active-controlled phase 2/3 study (NCT05522231) designed to evaluate the efficacy and safety of Fruquintinib (F) + Sintilimab versus Axitinib or Everolimus monotherapy for 2L treatment of RCC. Results from this F monotherapy of the FRUSICA-2 indicated a comparable anti-tumor efficacy compared with other 2L VEGFR-TKI monotherapies, along with a manageable safety profile in 2L RCC pts after first-line VEGFR-TKI therapy."

Clinical • Metastases • Monotherapy • P2 data • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

A Study to Evaluate the Efficacy and Safety of IBI310 and Sintilimab Combination Therapy in Patients With Hepatocellular Carcinoma as First-line Treatment. (clinicaltrials.gov) - P2/3 | N=680 | Not yet recruiting | Sponsor: Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD.

New P2/3 trial • Hepatocellular Cancer • Oncology • Solid Tumor

A Real-World, Single-Arm Study Protocol of Disitamab Vedotin in Combination With Immunotherapy and Multimodal Radiation Therapy for HER2-Positive Advanced Gastric Cancer: After Second-Line Treatment Failure (clinicaltrials.gov) - P=N/A | N=30 | Not yet recruiting | Sponsor: West China Hospital

IO biomarker • New trial • Real-world evidence • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor • HER-2

ACTION-I: TACE or Ablation Combined With Sintilimab and Ipilimumab N01 as Neoadjuvant Therapy for Resectable Hepatocellular Carcinoma With Intermediate-High Recurrence Risk (clinicaltrials.gov) - P2 | N=90 | Not yet recruiting | Sponsor: Sun Yat-sen University

New P2 trial • Hepatocellular Cancer • Oncology • Solid Tumor

Neoadjuvant chemoradiotherapy with or without PD-1 inhibitors in MMR-proficient non-metastatic rectal cancer: a meta-analysis of randomized controlled trials. (PubMed, Front Immunol) - "Six trials (n=935; nCRT+PD 1 = 461; nCRT=474) were included; agents evaluated included pembrolizumab, sintilimab, tislelizumab and camrelizumab. Among patients with pMMR non-metastatic rectal cancer, adding PD-1 inhibitors to standard nCRT improves pCR-most markedly when combined with short-course radiotherapy-with no statistically significant increase detected in high-grade neoadjuvant toxicity or major surgical morbidity. These randomized data support progression to confirmatory phase III trials to define optimal sequencing, regimen standardization and long-term oncologic and functional outcomes.Systematic Review Registration: https://www.crd.york.ac.uk/prospero/, identifier 420251137668."

Clinical • Journal • Retrospective data • Review • Colorectal Cancer • Oncology • Rectal Cancer • Solid Tumor

Efficacy and Safety of Combination Therapy With Immune Checkpoint Inhibitors and Chemotherapy With Gemcitabine and Nab-Paclitaxel in Pancreatic Cancer: A Systematic Review. (PubMed, Cancer Med) - "Combining ICIs with gemcitabine and nab-paclitaxel appears feasible and safe, with signals of improved efficacy compared with chemotherapy alone. However, evidence remains limited, and further large-scale trials are warranted to confirm survival benefits and optimize therapeutic strategies in pancreatic cancer."

Checkpoint inhibition • Journal • Review • Fatigue • Hematological Disorders • Neutropenia • Oncology • Pain • Pancreatic Cancer • Solid Tumor

Becotatug Vedotin Plus Sintilimab in Locoregionally Advanced NPC (clinicaltrials.gov) - P3 | N=266 | Recruiting | Sponsor: First Affiliated Hospital of Guangxi Medical University

New P3 trial • Head and Neck Cancer • Nasopharyngeal Carcinoma • Oncology • Solid Tumor

A Single-arm, Multicenter Clinical Study of Becotatug Vedotin Combined With Zimberelimab in the Treatment of Recurrent and Metastatic Cervical Cancer, Vulvar Cancer and Vaginal Cancer (clinicaltrials.gov) - P2 | N=30 | Not yet recruiting | Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

New P2 trial • Cervical Cancer • Gynecologic Cancers • Oncology • Solid Tumor • Vaginal Cancer • Vulvar Cancer

Short-course radiotherapy followed by sintilimab and CAPOX as total neoadjuvant treatment in locally advanced rectal cancer: A prospective, randomized controlled trial (SPRING-01). (ASCO 2025) - P4 | "In LARC patients, SCRT combined with sintilimab and CAPOX as a TNT significantly increases the pCR rate while maintaining manageable safety in patients with LARC. SCRT followed by sintilimab and CAPOX can be recommended as a superior neoadjuvant treatment option for these patients. The efficacy of SIN+CAPOX and surgical and pathological results.Abbreviations: IQR, interquartile range; N, regional nodal category; T, primary tumor category; yp, pathologic."

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

Sintilimab plus cisplatin and nab-paclitaxel induction treatment for locally advanced borderline resectable esophageal squamous cell carcinoma: A single-arm, prospective, phase 2 study (NEOCRTEC2001) (AACR 2026) - "Abstract is embargoed at this time."

Clinical • Metastases • P2 data • Esophageal Squamous Cell Carcinoma • Oncology • Squamous Cell Carcinoma

ABT score based clinical model predicts prognosis in unresectable hepatocellular carcinoma treated with TACE combined with Bevacizumab and Sintilimab therapy (APASL 2026) - No abstract available

Clinical • Hepatocellular Cancer • Oncology • Solid Tumor

AADN score: Predicting Response to transarterial chemoembolization, sintilimab and lenvatinib in patients with hepatocellular carcinoma (APASL 2026) - No abstract available

Clinical • Hepatocellular Cancer • Oncology • Solid Tumor

Development and validation of the FAAP model for prognostic stratification in HCC patients treated with TACE, sintilimab plus bevacizumab: a multicenter study (APASL 2026) - No abstract available

Clinical • Hepatocellular Cancer

Sintilimab Plus Axitinib for Advanced Fumarate Hydratase-Deficient Renal Cell Carcinoma: A Phase 2 Nonrandomized Clinical Trial. (PubMed, JAMA Oncol) - P2 | "This combination therapy warrants further validation in a randomized clinical trial. ClinicalTrials.gov Identifier: NCT04387500."

Clinical • Journal • P2 data • Dyslipidemia • Genito-urinary Cancer • Hematological Disorders • Hypertriglyceridemia • Kidney Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • FH