This study is a prospective, open-label, two-arm exploratory Phase II clinical trial aimed at observing and evaluating the efficacy and safety of combined therapy with cadonilimab and fruquintinib in conjunction with paclitaxel-albumin as second-line treatment for advanced gastric/esophagogastric junction adenocarcinoma. Patients meeting the inclusion criteria were divided into two groups based on whether they had received PD-1/L1 antibody treatment in the first line: Group A (immunotherapy-naive group - patients who had previously failed standard chemotherapy in the first line) and Group B (immunotherapy rechallenge group - patients who had previously failed PD-1/L1 antibody combined chemotherapy in the first line). All patients received combined therapy with cadonilimab and fruquintinib in conjunction with paclitaxel-albumin until intolerable toxic reactions occurred, disease progression, withdrawal of informed consent by the subject, loss to follow-up, death, other conditions judged by the investigator to require termination of treatment, or termination of the study, whichever occurred first. The maximum duration of paclitaxel-albumin treatment was 6 cycles, and cadonilimab treatment did not exceed 1 year. Clinical tumor imaging evaluations were conducted every 8 weeks during treatment using RECIST v1.1 criteria, and safety assessments were performed using CTCAE 5.0, recording adverse events within 30 days from the first dose to the end of treatment.
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Parallel
Cadonilimab and Fruquintinib Combined With Paclitaxel-albumin
DrugCadonilimab : 6mg/kg (≤375mg) d1,15 s.c. Q4W; Fruquintinib: 3mg p.o. Q.d d1-21,Q4W.; Paclitaxel-albumin: 100 mg/m2 d1,8,15 stop for one week, i.v. Q4W
Objective Response Rate (ORR)
ORR was defined as the percentage of participants with measurable lesions achieving a Complete Response (CR; disappearance of all target lesions) or Partial Response (PR; at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters) based on Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST v1.1) criteria.
Progression-free Survival (PFS)
Time from the date of randomization to the date of progressive disease (PD) or death, whichever occurs first.
Disease Control Rate (DCR)
The proportion of participants who achieves a best overall response of CR, PR or stable disease(SD).
Duration of Response (DoR)
The time from the date that response criteria are first met to the date that progressive disease (PD) is objectively documented or death, whichever occurs first.
Overall Survival (OS)
OS is defined as the time from enrollment to death from any cause.
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