This is a single-center, open-label, single-arm, exploratory phase II clinical trial designed to evaluate the preliminary efficacy and safety of sintilimab in combination with oral gossypol acetate in patients with advanced pMMR/MSS colorectal cancer after failure of at least two prior lines of standard therapy. Eligible participants will have histologically or cytologically confirmed advanced colorectal adenocarcinoma, measurable disease according to RECIST version 1.1, ECOG performance status of 0 or 1, and adequate organ function. Participants will receive oral gossypol acetate once daily, followed by sintilimab administered intravenously every 3 weeks after a gossypol acetate lead-in period. The primary outcome is objective response rate assessed by RECIST version 1.1. Secondary outcomes include disease control rate, progression-free survival, overall survival, duration of response, and safety.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
32
Sintilimab 200 mg will be administered intravenously every 3 weeks for 3 cycles after a gossypol acetate lead-in period, according to the study protocol.
Gossypol acetate 20 mg will be administered orally once daily after dinner for 9 weeks, according to the study protocol.
Peking University People's Hospital
Beijing, Beijing Municipality, China
Objective Response Rate
Objective response rate is defined as the proportion of participants who achieve complete response or partial response as their best overall response, as assessed according to RECIST version 1.1 by independent radiologic review.
Time frame: At Week 11 after initiation of study treatment
Disease Control Rate
Disease control rate is defined as the proportion of participants who achieve complete response, partial response, or stable disease as their best overall response according to RECIST version 1.1.
Time frame: At Week 11 after initiation of study treatment
Progression-Free Survival
Progression-free survival is defined as the time from the first dose of study treatment to the first documented disease progression according to RECIST version 1.1 or death from any cause, whichever occurs first.
Time frame: From the first dose of study treatment up to 24 months
Overall Survival
Overall survival is defined as the time from the first dose of study treatment to death from any cause.
Time frame: From the first dose of study treatment up to 24 months
Duration of Response
Duration of response is defined as the time from the first documented complete response or partial response to disease progression or death from any cause, whichever occurs first.
Time frame: From the first documented response up to 24 months
Adverse events (AEs) were graded according to the NCI CTCAE version 5.0
Adverse events, serious adverse events, treatment-related adverse events, and immune-related adverse events will be assessed and graded according to NCI CTCAE version 5.0.
Time frame: From the first dose of study treatment through 30 days after the last dose of study treatment
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