AiZeLi (retlirafusp alfa) / Jiangsu Hengrui Pharma, Dong-A - LARVOL DELTA

A Clinical Study of SHR-1701 Combined with Chemotherapy for the Perioperative Treatment of Locally Advanced Resectable Siewert Type II Adenocarcinoma of the Esophagogastric Junction. (ESMO-IO 2026) - No abstract available

Clinical • Metastases • Esophageal Adenocarcinoma • Gastroesophageal Junction Adenocarcinoma • Oncology

H-FROG: Perioperative Retlirafusp Alfa(Anti-PD-L1/TGF-β Bifunctional Fusion Protein) Plus Famitinib and GEMOX-Based Hepatic Arterial Infusion Chemotherapy for Locally Advanced Intrahepatic Cholangiocarcinoma: A Multicenter, Single-Arm, Exploratory Phase II Trial (clinicaltrials.gov) - P2 | N=81 | Recruiting | Sponsor: The First Affiliated Hospital with Nanjing Medical University

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

Retlirafusp Alfa Improves Overall Survival in Phase 3 Trial of HER2– Gastric Cancer (Targeted Oncology) - "Retlirafusp alfa plus chemotherapy significantly improved overall survival (OS) and progression-free survival (PFS) compared with chemotherapy alone in patients with previously untreated, unresectable, locally advanced or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma, according to findings from the phase 3 RELIGHT trial (NCT04950322) published in the Journal of Clinical Oncology...Among patients with a PD-L1 combined positive score (CPS) of 5 or higher, median OS was 16.8 months with retlirafusp alfa plus capecitabine and oxaliplatin (CAPOX) compared with 10.4 months with placebo plus CAPOX (HR, 0.53; 95% CI, 0.40-0.68; 1-sided P < .0001). In the overall intention-to-treat (ITT) population, median OS was 15.8 months vs 11.2 months, respectively (HR, 0.66; 95% CI, 0.53-0.81; 1-sided P < .0001)."

P3 data • Gastric Adenocarcinoma • Gastroesophageal Junction Adenocarcinoma

FLYFLY: SHR-1701 Combined With Fluzoparib in Lung Squamous Cell Carcinoma (clinicaltrials.gov) - P2 | N=71 | Not yet recruiting | Sponsor: Hunan Province Tumor Hospital

New P2 trial • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

FLYFLY: SHR-1701 Combined With Fluzoparib in Lung Squamous Cell Carcinoma (clinicaltrials.gov) - P2 | N=71 | Recruiting | Sponsor: Hunan Province Tumor Hospital | Not yet recruiting ➔ Recruiting

Enrollment open • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

FLYFLY: SHR-1701 Combined With Fluzoparib in Lung Squamous Cell Carcinoma (clinicaltrials.gov) - P2 | N=71 | Recruiting | Sponsor: Hunan Province Tumor Hospital | Trial completion date: Jun 2022 ➔ Jun 2024 | Trial primary completion date: Dec 2021 ➔ Dec 2023

Trial completion date • Trial primary completion date • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

FLYFLY: SHR-1701 Combined With Fluzoparib in Lung Squamous Cell Carcinoma (clinicaltrials.gov) - P2 | N=71 | Recruiting | Sponsor: Hunan Province Tumor Hospital | Trial completion date: Jun 2024 ➔ Jun 2025 | Trial primary completion date: Dec 2023 ➔ Dec 2024

Trial completion date • Trial primary completion date • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

SHR-1701 in Combination With Irinotecan Liposome (II) for Second-line Treatment of ESCC After Immunotherapy (clinicaltrials.gov) - P2 | N=33 | Not yet recruiting | Sponsor: Zhigang Li

New P2 trial • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Oncology

An Umbrella-designed Prospective Multicenter Randomized Open-label Superiority Trial Evaluating Multi-biomarker-guided Precision Therapy for First-line Treatment of Advanced Esophageal Squamous Cell Carcinoma (clinicaltrials.gov) - P2 | N=347 | Not yet recruiting | Sponsor: Sun Yat-sen University

Biomarker • Head-to-Head • IO biomarker • New P2 trial • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Oncology

Low-Dose Radiotherapy With Retlirafusp Alfa and Chemotherapy as Neoadjuvant Therapy for Resectable Locally Advanced Esophageal Squamous Cell Carcinoma (clinicaltrials.gov) - P2 | N=96 | Active, not recruiting | Sponsor: Harbin Medical University

New P2 trial • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Oncology

Retlirafusp Alfa Plus Chemotherapy as Neoadjuvant Therapy for Thoracic ESCC (clinicaltrials.gov) - P2 | N=33 | Not yet recruiting | Sponsor: Tang-Du Hospital

New P2 trial • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Oncology

Retlirafusp Alfa Combined With Chemoradiotherapy in Unresectable ESCC (clinicaltrials.gov) - P=N/A | N=68 | Not yet recruiting | Sponsor: RenJi Hospital

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

An Exploratory Clinical Study of Accurate Efficacy Assessment of Neoadjuvant Immunotherapy in Locally Advanced Esophageal Squamous Cell Carcinoma Based on 68Ga-FAPI ([68Ga] Fibroblast Activation Protein Inhibitor)/¹⁸F-FDG (2-Deoxy-2-[¹⁸F]Fluoro-D-glucose) Dual Imaging (clinicaltrials.gov) - P2 | N=92 | Not yet recruiting | Sponsor: Tan Lijie

New P2 trial • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Oncology

Retlirafusp Alfa Injection Plus Chemotherapy Versus Investigator's Choice of Anti-PD-1 Antibody Plus Chemotherapy as First-line Treatment for Advanced Gastric Cancer With Liver Metastases (clinicaltrials.gov) - P3 | N=332 | Not yet recruiting | Sponsor: Peking University

New P3 trial • Esophageal Cancer • Gastric Adenocarcinoma • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor

First-Line Retlirafusp Alfa Plus Chemotherapy for Human Epidermal Growth Factor Receptor 2-Negative Gastric or Gastroesophageal Junction Adenocarcinoma: A Randomized, Double-Blind, Phase III Study (RELIGHT). (PubMed, J Clin Oncol) - "Retlirafusp alfa plus CAPOX represents a first-line treatment option for unresectable, locally advanced or metastatic, HER2-negative gastric or gastroesophageal junction adenocarcinoma. A key limitation is that chemotherapy alone served as the comparator, given that the study protocol was finalized before PD-1 inhibitor plus chemotherapy became the approved standard-of-care regimen in China."

Clinical • Journal • P3 data • Gastric Adenocarcinoma • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor • HER-2

Retlirafusp Alfa Combined With Zeprumetostat, Apatinib, and Chemotherapy as First-Line Treatment for Metastatic GC/GEJC (clinicaltrials.gov) - P2 | N=55 | Not yet recruiting | Sponsor: Fudan University

New P2 trial • Esophageal Cancer • Gastric Cancer • Gastroesophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor

Retlirafusp alfa Combined with Rivoceranib, With or Without Zeprumetostat, in Patients with Advanced Gastric Cancer Who Have Failed First-Line Immunotherapy (ESMO 2026) - No abstract available

Clinical • Metastases • Gastric Cancer • Oncology • Solid Tumor

MA-GC-II-023: Establishment of Precision Targeted Therapy Strategies for Advanced Gastric Cancer Based on Novel Molecular Subtyping (clinicaltrials.gov) - P2 | N=140 | Not yet recruiting | Sponsor: China Medical University, China

New P2 trial • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor

Retlirafusp Alfa Combined With Chemotherapy or Fuzuloparib for Triple-Negative Breast Cancer (clinicaltrials.gov) - P2 | N=120 | Not yet recruiting | Sponsor: Harbin Medical University

New P2 trial • Breast Cancer • Hormone Receptor Negative Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • BRCA1 • BRCA2 • ER • HER-2 • PGR

Safety and Efficacy of SHR2554 Combined With Other Antitumor Therapies in Gastric or Gastro-oesophageal Junction Adenocarcinoma (clinicaltrials.gov) - P2 | N=351 | Recruiting | Sponsor: Jiangsu HengRui Medicine Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Esophageal Cancer • Gastric Cancer • Gastroesophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor

A prospective, randomized, controlled phase II study of stereotactic body radiotherapy (SBRT) plus SHR-1701 versus SBRT alone in asymptomatic or mildly symptomatic patients with metastatic castration-resistant prostate cancer (ESMO 2026) - P2 | "Eligible patients progressed on ≥1 novel hormonal therapy and received, are intolerant to, or refused docetaxel, while maintaining ADT. Assuming median rPFS of 6 months (control) vs 12 months (experimental), 58 patients provide 80% power (one-sided α=0.05, log-rank test). With a 10% dropout rate, 66 patients will be enrolled between March 2026 and January 2027."

Clinical • Metastases • P2 data • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • TGFB1

MULAN: Molecularly Targeted Umbrella Study in Luminal Advanced Breast Cancer (clinicaltrials.gov) - P2 | N=319 | Recruiting | Sponsor: Fudan University | Not yet recruiting ➔ Recruiting | N=170 ➔ 319

Enrollment change • Enrollment open • Breast Cancer • Oncology • Solid Tumor • ER • HER-2 • PGR

ICT-HCC: Individualized Comprehensive Treatment for Advanced Hepatocellular Carcinoma (clinicaltrials.gov) - P=N/A | N=270 | Recruiting | Sponsor: Nanjing Tianyinshan Hospital | Trial completion date: Mar 2028 ➔ Dec 2028 | Trial primary completion date: Mar 2027 ➔ Dec 2027

IO biomarker • Trial completion date • Trial primary completion date • Hepatocellular Cancer • Oncology • Solid Tumor • PD-L1

Safety and Efficacy of SHR2554 Combined With Other Antitumor Therapies in Gastric or Gastro-oesophageal Junction Adenocarcinoma (clinicaltrials.gov) - P2 | N=351 | Not yet recruiting | Sponsor: Jiangsu HengRui Medicine Co., Ltd.

New P2 trial • Esophageal Cancer • Gastric Cancer • Gastroesophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor

MULAN: Molecularly Targeted Umbrella Study in Luminal Advanced Breast Cancer (clinicaltrials.gov) - P2 | N=170 | Not yet recruiting | Sponsor: Fudan University

New P2 trial • Breast Cancer • Oncology • Solid Tumor • ER • HER-2 • PGR