This is a prospective, single-arm, investigator-initiated phase II clinical study. The study evaluates the efficacy and safety of retlirafusp alfa (a PD-L1/TGF-βRII bifunctional fusion protein) combined with apatinib (a VEGFR-2 tyrosine kinase inhibitor) and nab-paclitaxel in patients with locally advanced unresectable, locally recurrent, or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma who have progressed after first-line immunotherapy-containing treatment.
Gastric cancer is one of the most common malignant tumors of the digestive system. For patients with advanced gastric cancer who have failed first-line immunotherapy plus chemotherapy, second-line treatment options remain limited. Retlirafusp alfa is a bifunctional fusion protein targeting PD-L1 and TGF-βRII. Apatinib is a small-molecule anti-angiogenic agent. Nab-paclitaxel is a chemotherapeutic agent recommended for second-line treatment of advanced gastric cancer. This prospective, single-arm study investigates the efficacy and safety of this triple combination regimen in immunotherapy-pretreated advanced second-line gastric or gastroesophageal junction adenocarcinoma, to provide a new therapeutic option for these patients.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Retlirafusp alfa: 1800 mg, intravenous infusion, day 1, every 3 weeks; until disease progression, unacceptable toxicity, or withdrawal; maximum 2 years Apatinib: 250 mg, oral, once daily; until disease progression, unacceptable toxicity, or withdrawal Nab-paclitaxel: 260 mg/m², intravenous infusion, day 1, every 3 weeks; for 4-6 cycles
Henan Cancer Hospital
Zhengzhou, Henan, China
Objective Response Rate (ORR)
Proportion of patients achieving complete response (CR) or partial response (PR) per RECIST 1.1 criteria, assessed every 6 weeks
Time frame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months after the last subject enrolled
Disease Control Rate (DCR)
Proportion of patients achieving CR, PR, or stable disease (SD) per RECIST 1.1
Time frame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months after the last subject enrolled
Progression-Free Survival (PFS)
Time from enrollment to disease progression or death from any cause
Time frame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months after the last subject enrolled
Overall Survival (OS)
Time from enrollment to death from any cause
Time frame: From date of enrollment until the date of death from any cause, assessed up to 12 months after the last subject enrolled
Duration of Response (DoR)
Time from first documented response to disease progression or death
Time frame: From first response to progression or death, up to 10 months after the last subject enrolled
Incidence and severity of adverse events (AEs)
Incidence and severity of adverse events per NCI CTCAE v5.0
Time frame: From informed consent until 30 days after last dose, assessed up to 7 months after the last subject enrolled
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