his study was a single-arm, open, single-center Phase ii clinical trial to observe and evaluate the efficacy and safety of CAPOX+ bevacizumab + tislelizumab in first-line treatment of ADVANCED gastroesophageal adenocarcinoma with CPS \< 5. This study targeted advanced gastric cancer patients who could not undergo radical treatment, who had not received systemic therapy before, or who had recurrence and metastasis more than 6 months after the end of adjuvant therapy. The 6-month progression-free survival (PFS) rate will be used as the primary outcome indicator, and approximately 30 subjects will be enrolled. Subject will receive CAPOX+ bevacizumab + tislelizumab continuously for a treatment cycle of 3 weeks after fully informed and signing informed consent, oxaliplatin will be stopped after 4-8 cycles, and other drugs will continue to be used until the treatment interruption event specified in the plan occurs. Post-treatment follow-up for safety and survival will continue after completion of treatment, and follow-up for tumor progression will also be conducted after completion of treatment for subjects who have not finished treatment for a cause of disease progression/death. After the subjects were enrolled in the study, safety visits were conducted for each treatment cycle D1 before medication. Imaging will be performed every 2 cycles from the first year of treatment to assess efficacy, and every 3 cycles after 1 year until treatment ends, informed consent is withdrawn, or death.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
32
Oxaliplatin: intravenous infusion, 130mg/m2, infusion for more than 3h, every 3 weeks for a cycle, infusion 4-8 cycles; Capecitabine: oral administration, 2g/m2, 2 times, 14 days, 7 days rest, every 3 weeks for a cycle; Bevacizumab was administered intravenously (without prophylaxis) at 7.5mg/kg. The first infusion was 90min, the second infusion was 60min, and each infusion was 30 min. The drug was administered once every 3 weeks, and the longest cumulative duration was 2 years. Tislelizumab is administered intravenously (without prophylaxis) at a fixed dose of 200mg. Each infusion was 30 min (no less than 20 min, no more than 60 min), and the drug was given once every 3 weeks for a cycle, with the longest cumulative duration of 2 years.
Chinese PLA General Hospital
Beijing, China
6-month progression-free survival
Probability of disease-free progression within 6 months in patients with complete remission and in patients with partial remission or disease progression
Time frame: Six months from the start of treatment
ORR(Objective Response Rate)
The proportion of patients whose tumors shrink by a certain amount and remain so for a certain amount of time, including CR+PR cases.
Time frame: Imaging tests were performed every 6 weeks (±7 days) from the first year of treatment to assess efficacy, and every 9 weeks (±7 days) after 1 year
PFS(progression-free survival)
Time from randomness to the first occurrence of disease progression or death from any cause.
Time frame: Imaging tests were performed every 6 weeks (±7 days) from the first year of treatment to assess efficacy, and every 9 weeks (±7 days) after 1 year
OS(Overall Survival)
Time from randomization to death from any cause
Time frame: Imaging tests were performed every 6 weeks (±7 days) from the first year of treatment to assess efficacy, and every 9 weeks (±7 days) after 1 year
Time to Response (TTR)
TTR was defined as the time from randomization to the first occurrence of CR or PR.
Time frame: From enrollment to the end of treatment at 8 weeks
Adverse Event
The dose suspension rate and dose termination rate caused by adverse events were determined according to NCI-CTCAE V5.0 standard
Time frame: Safety visits were made before medication in each treatment cycle day1(every cycle is 21days)
Duration of Response (DOR)
duration of response (DOR) defined as the period between the first objective response and the first documented PD or death of any cause.
Time frame: From enrollment to the end of treatment at 8 weeks
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