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

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

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

Clinical study to evaluate the safety, tolerability, immunogenicity, and preliminary efficacy of a tumor vaccine targeting specific EGFR mutations as monotherapy and combination therapy in patients with EGFR-mutated non-small cell lung cancer (ChiCTR) - P1 | N=75 | Recruiting | Sponsor: The First Affiliated Hospital of Nanyang Medical College; The First Affiliated Hospital of Nanyang Medical College

New P1 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Sintilimab plus bevacizumab combined with radiotherapy as first-line treatment for hepatocellular carcinoma with portal vein tumor thrombus: A multicenter, single-arm, phase 2 study. (PubMed, Hepatology) - P2 | "Sintilimab plus bevacizumab combined with radiotherapy provides favorable treatment response and survival outcomes along with an acceptable safety profile in the first-line setting for HCC patients with PVTT. (ClinicalTrials.gov Identifier: NCT05010434)."

Journal • P2 data • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Solid Tumor • Thrombosis

A Randomized, Controlled, Multicenter Phase Ⅲ Trial of Sintilimab as Consolidation Therapy in Unresectable ESCC Patients Without Disease Progression After Concurrent Taxane-Based Chemoradiotherapy (ChiCTR) - P=N/A | N=258 | Completed | Sponsor: Jiangsu Cancer Hospital; Jiangsu Cancer Hospital

New trial • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Oncology

Sintilimab Combined With Stereotactic Body Radiotherapy as Neoadjuvant Therapy for Resectable Hepatocellular (ChiCTR) - P2 | N=110 | Not yet recruiting | Sponsor: Shandong First Medical University and Shandong Academy of Medical Sciences (Shandong Cancer Hospital &Institute); Shandong First Medical Universit

New P2 trial

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

Neoadjuvant Chemotherapy Combined With Sintilimab and Bevacizumab for TNBC (NEOTORCH-BREAST07) (clinicaltrials.gov) - P2 | N=37 | Recruiting | Sponsor: First Affiliated Hospital of Zhejiang University

New P2 trial • Breast Cancer • Hormone Receptor Negative Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • ER • HER-2 • PD-L1 • PGR

THE EFFICACY AND SAFETY OF PD-1 MONOCLONAL ANTIBODY IN THE TREATMENT OF HEMOPHAGOCYTIC SYNDROME:SYSTEMATIC REVIEW (EBMT 2026) - "Data regarding the efficacy and safety of PD-1 monoclonal antibodies used (such as sintilimab, nivolumab, camrelizumab, and tislelizumab) in both pediatric and adult patients with HLH were included...In pediatric patients (aged 3–7 years) with CAEBV and r/r EBV-HLH, sintilimab (3mg/kg, once every 3-4 weeks, monotherapy or combined with L-DEP regimen (pegaspargase, liposomal doxorubicin, etoposide, and high-dose methylprednisolone)) induced partial or complete clinical remission and significantly reduced plasma EBV-DNA levels (>50%), successfully serving as a bridge to allogeneic hematopoietic stem cell transplantation (HSCT) in some cases...Furthermore, novel combinations with ruxolitinib, venetoclax, or thalidomide achieved rapid clinical remission in EBV-HLH... PD-1 monoclonal antibodies demonstrate significant therapeutic potential as salvage therapy for r/r EBV-HLH, effectively reducing viral loads and inducing remission. However, immune checkpoint inhibition acts..."

Clinical • Review • Bone Marrow Transplantation • Epstein-Barr Virus Infections • Graft versus Host Disease • Hematological Malignancies • Hemophagocytic lymphohistiocytosis • Immunology • Lymphoma • Natural Killer/T-cell Lymphoma • Rare Diseases • T Cell Non-Hodgkin Lymphoma

A randomized controlled study of preoperative short-course radiotherapy + chemotherapy and immunotherapy combined with intestinal flora intervention for locally advanced middle and low rectal cancer (ChiCTR) - P2 | N=216 | Not yet recruiting | Sponsor: The First Affiliated Hospital of Xi'an Jiaotong University; The First Affiliated Hospital of Xi'an Jiaotong University

New P2 trial • Colorectal Cancer • Oncology • Rectal Adenocarcinoma • Rectal Cancer • Solid Tumor

Efficacy and Safety of Multi-mode Thermal Therapy Combined with Paclitaxel plus Gemcitabine (AG Regimen) as First-Line Treatment for Pancreatic Cancer with Liver Metastases: A Prospective Single-Arm Study (ChiCTR) - P=N/A | N=6 | Not yet recruiting | Sponsor: The Affiliated Hospital of Qingdao University; The Affiliated Hospital of Qingdao University

New trial • Oncology • Pancreatic Cancer • Solid Tumor

Immune checkpoint inhibitor-related Stevens-Johnson syndrome and toxic epidermal necrolysis: a retrospective analysis of 21 cases. (PubMed, Front Immunol) - "The median latency from ICI initiation to onset was 28 days, most commonly following PD-1 inhibitors such as sintilimab and tislelizumab. Increased awareness and further studies are needed to clarify its mechanisms and guide management. Based on our findings, we recommend heightened vigilance for early mucocutaneous symptoms in patients receiving ICIs, prompt dermatology referral for suspected cases, and establishment of standardized reporting pathways to national pharmacovigilance systems to ensure rapid identification and pooled analysis of ICI-related SJS/TEN cases."

Checkpoint inhibition • Journal • Retrospective data • Dermatology • Oncology • Steven-Johnson Syndrome

Surufatinib combined with sintilimab and IBI310 for the treatment of high-grade advanced-neuroendocrine neoplasms: A single arm, open-label, single-center, phase II study. (PubMed, Int J Cancer) - P2 | "Serious adverse events occurred in 45.2% of patients. These findings suggest that surufatinib, IBI310, and sintilimab may offer clinical benefit with manageable toxicity in patients with advanced HG-NENs."

Journal • P2 data • Endocrine Cancer • Neuroendocrine Carcinoma • Oncology • Solid Tumor

Effectiveness and mechanisms of lymphocytes at different time points in predicting consolidation immunotherapy following adaptive chemoradiotherapy in locally advanced non-small cell lung cancer. (PubMed, Front Oncol) - "This retrospective analysis enrolled 139 patients with stage III NSCLC (median age 69 years; 95% male; 84.17% squamous cell carcinoma) who received adaptive chemoradiotherapy (CRT) and consolidation anti-PD-1 therapy (sintilimab)...The Kaplan-Meier analysis further showed that patients with higher CD8+ T-cell counts at 1 month post-radiotherapy had significantly longer OS (p < 0.05). In patients with locally advanced NSCLC receiving chemoradiotherapy followed by consolidation immunotherapy, higher ALCs and elevated CD8+ T-cell counts at 1 month post-chemoradiotherapy are associated with improved overall survival."

Journal • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • CD4 • CD8

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

Organ Preservation in Patients With Early-Stage (cT2-3a/bN0M0) Mismatch Repair Proficient Low Rectal Carcinoma Via Neoadjuvant Short-Course Radiotherapy Followed by Chemotherapy Combined With PD-1 Inhibitor :A Prospective, Multicenter, Single-Arm, Phase II Trial (ChiCTR) - P2 | N=33 | Not yet recruiting | Sponsor: The Sixth Affiliated Hospital of Sun Yat-sen University; The Sixth Affiliated Hospital of Sun Yat-sen University

New P2 trial • Colorectal Cancer • Oncology • Rectal Adenocarcinoma • Rectal Cancer • Solid Tumor

PRIME-PCNSL: A Multicenter Two-Cohort Study of Methotrexate, Rituximab, Sintilimab and Pirtobrutinib for Treatment-Naive PCNSL vs. Real-World Investigator-Selected Treatment (Observational Cohort) (clinicaltrials.gov) - P2 | N=110 | Recruiting | Sponsor: Tongji Hospital

New P2 trial • Real-world evidence • B Cell Lymphoma • CNS Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Primary Central Nervous System Lymphoma

Case report: Immune checkpoint inhibitor-induced fulminant diabetic ketoacidosis: a case-based review and considerations for immunotherapy discontinuation. (PubMed, Front Immunol) - "An elderly male diagnosed with Stage IV LUAD achieved sustained stable disease (SD) and symptomatic improvement through a sequential therapeutic strategy, including platinum-based chemotherapy followed by the PD-1 inhibitor sintilimab combined with anti-angiogenic agents (apatinib or anlotinib). This case demonstrates that while ICIs can provide exceptional long-term benefits in advanced NSCLC, particularly in patients with highly immunogenic mutation profiles, they may also trigger late-onset fatal irAEs. Our findings underscore the imperative for close, long-term metabolic surveillance throughout the course of immunotherapy, regardless of treatment duration or radiological stability."

Checkpoint inhibition • IO biomarker • Journal • Review • Diabetes • Endocrine Cancer • Lung Adenocarcinoma • Lung Cancer • Metabolic Disorders • Non Small Cell Lung Cancer • Oncology • Solid Tumor • KRAS • TP53

Surgical management of giant Xp11.2 translocation renal cell carcinoma with multivisceral invasion: a case report of en bloc resection and targeted-immunotherapy success. (PubMed, Front Oncol) - "Surveillance MRI at 3 months postoperatively revealed local recurrence, prompting combination therapy with sunitinib (VEGF inhibitor) and sintilimab (anti-PD-1 antibody). Follow-up imaging demonstrated significant regression at 1 month, with no evidence of disease progression at 12-month reassessment."

Journal • Genito-urinary Cancer • Kidney Cancer • Oncology • Pancreatic Cancer • Renal Cell Carcinoma • Sarcoma • Solid Tumor • TFE3

Prospective Study on Adjuvant Therapy After Resection for Ruptured Hepatocellular Carcinoma with Hemorrhage: A Prospective Exploratory Single-Arm Study of Adjuvant Sintilimab Combined with Bevacizumab (CLEAR-2 Study) (ChiCTR) - P4 | N=30 | Not yet recruiting | Sponsor: Ruijin Hospital, Shanghai Jiao Tong University School of Medicine; Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

New P4 trial • Hematological Disorders • Hepatocellular Cancer • Oncology • Solid Tumor

A Single-Arm, Single-Center, Prospective Phase II Clinical Study of Stephania Longa and Jiezai Rice Combined with Sintilimab in Advanced Driver Gene-Negative, PD-L1-Positive NSCLC Patients Who Failed First-Line Immunotherapy (ChiCTR) - P=N/A | N=29 | Recruiting | Sponsor: Hainan General Hospital; Hainan General Hospital

New trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EGFR • PD-L1 • RET • ROS1

Iparomlimab and tuvonralimab (QL1706) with bevacizumab and/or chemotherapy in first-line (1L) treatment of advanced hepatocellular carcinoma (aHCC): A randomized, open-label, phase II/III study (DUBHE-H-308) (ESMO 2024) - P2/3 | "Thus the Phase 2 part of DUBHE-H-308 study (NCT05976568) investigating QL1706 with bev and/or chemotherapy (chemo) for 1L treatment of aHCC was conducted and the results were reported here. Patients (pts) were randomly assigned (1:1:1:1) to the arm 1 QL1706 (7.5 mg/kg, Q3W) + bev (15 mg/kg, Q3W)+chemo (aHCC regimen, namely oxaliplatin 85 mg/m2 plus capecitabine 1000 mg/m2, Q3W, up to 4 cycles), the arm 2 QL1706 + bev, the arm 3 QL1706 + chemo, or the arm 4 another PD-1 antibody sintilimab (200 mg, Q3W)+ bev. In the Phase 2 part of DUBHE-H-308 study, QL1706 plus bev with chemo showed encouraging preliminary efficacy and a manageable safety profile in 1L treatment of aHCC. QL1706 + bev + XELOX was selected as study arm by Independent Data Monitoring Committee for future Phase 3 study."

Clinical • Late-breaking abstract • Metastases • P2/3 data • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology

HAIC in Combination With PD-1 Inhibitors and Lenvatinib for High Tumor Burden Advanced HCC (CHANCE2416) (clinicaltrials.gov) - P=N/A | N=244 | Completed | Sponsor: First Hospital of China Medical University | Recruiting ➔ Completed

Trial completion • Hepatocellular Cancer • Oncology • Solid Tumor • Thrombosis

Clinical study on the efficacy difference of regorafenib combined with sintilimab in the later-line treatment of left and right-sided colorectal cancer (ChiCTR) - P4 | N=60 | Not yet recruiting | Sponsor: Chongqing University Cancer Hospital; Chongqing University Cancer Hospital

New P4 trial • Colorectal Adenocarcinoma • Colorectal Cancer • Oncology • Solid Tumor

Efficacy and Safety of Transarterial Chemoembolization Followed by Continuous Infusion Chemotherapy Combined with Bevacizumab Biosimilar and Sintilimab (the THBS Quadruple Regimen) for Unresectable Hepatocellular Carcinoma with High Tumor Burden: A Prospective Multicenter Exploratory Study (ChiCTR) - P=N/A | N=63 | Not yet recruiting | Sponsor: First Affiliated Hospital of the Army Medical University of the Chinese People's Liberation Army; First Affiliated Hospital of the Army Medical Univer

New trial • Hepatocellular Cancer • Oncology • Solid Tumor