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Safety and Efficacy of Fruquintinib Plus Nab-Paclitaxel and Iparomlimab and Tuvonralimab Injection in the Second-Line Treatment for Immunotherapy-experienced Advanced Gastric Cancer
Sponsor: Dai, Guanghai
Summary
Immunotherapy has established the new standard for first-line treatment of advanced or metastatic gastric cancer. However, current second-line options-predominantly consisting of targeted therapy plus chemotherapy or chemotherapy alone-confer only modest clinical benefit. Notably, pivotal phase III second-line trials (REGARD, RAINBOW, RAINBOW-Asia, FRUTIGA) exclusively enrolled patients who progressed on chemotherapy regimens; thus, high-quality evidence guiding second-line treatment specifically for immunotherapy-refractory patients remains scarce, representing a significant unmet medical need. Anti-angiogenic agents have demonstrated capacity to ameliorate the hypoxic, immunosuppressive tumor microenvironment while exerting synergistic anti-tumor effects when combined with immune checkpoint inhibitors. Exploratory studies evaluating immunotherapy combined with anti-angiogenic therapy plus chemotherapy in advanced gastric cancer patients after first-line failure have yielded encouraging efficacy signals (NCT03966118, NCT04982276), with objective response rates of 30-40% and median progression-free survival approaching 6 months. Based on this, the investigators aim to evaluate the efficacy and safety profile of fruquintinib combined with nab-paclitaxel and Iparomlimab and Tuvonralimab Injection (a novel bispecific antibody) as second-line treatment for patients with advanced gastric cancer who have experienced disease progression during or after first-line immunotherapy-containing regimens.
Official title: A Prospective, Single-Arm, Phase Ⅱ Clinical Trial Evaluating Fruquintinib in Combination With Paclitaxel for Injection (Albumin-bound) and Iparomlimab and Tuvonralimab Injection as Second-Line Therapy in Advanced Gastric Cancer Patients Previously Received Immunotherapy
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
68
Start Date
2025-12-01
Completion Date
2028-11-30
Last Updated
2026-02-11
Healthy Volunteers
No
Conditions
Interventions
Fruquintinib
3 mg qd, po, q3W; After 6 cycles of combination therapy, maintenance treatment consisting of Iparomlimab and Tuvonralimab Injection plus Fruquintinib will continue until disease progression, intolerable toxicity, initiation of new antitumor therapy, withdrawal of informed consent, or investigator's determination that the subject should discontinue from study treatment.
Iparomlimab and Tuvonralimab
5.0 mg/kg, Day 1, q3W, iv. After 6 cycles of combination therapy, maintenance treatment consisting of Iparomlimab and Tuvonralimab Injection plus Fruquintinib will continue until disease progression, intolerable toxicity, initiation of new antitumor therapy, withdrawal of informed consent, or investigator's determination that the subject should discontinue from study treatment.
Paclitaxel (albumin-bound)
250 mg/m², Day 1, q3W
Locations (1)
Chinese PLA General Hospital, Beijing
Beijing, Beijing Municipality, China