Sintilimab Plus Gossypol Acetate in Advanced Colorectal Cancer
ConditionAdvanced Colorectal Cancer
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorPeking University People's Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Written informed consent provided before any study-specific procedures.
Age 18 to 75 years, male or female.
Histologically or cytologically confirmed advanced colorectal adenocarcinoma.
Confirmed pMMR/MSS tumor status. Participants without documented MSI/MMR status must undergo MSI or MMR testing during screening.
Disqualifiers
Histology of small cell carcinoma, squamous cell carcinoma, or mixed carcinoma.
dMMR/MSI-H tumor status.
Complete bowel obstruction or clinical conditions likely to progress to bowel obstruction.
Suspected bowel perforation based on clinical symptoms or imaging.
Trial design
Design model
Single group
Treatments tested in this trial
Sintilimab
DrugSintilimab 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
DrugGossypol acetate 20 mg will be administered orally once daily after dinner for 9 weeks, according to the study protocol.
Treatment groups
32 Participants
are divided into 1 treatment groupGroup A: Experimental: Sintilimab Plus Gossypol AcetateExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
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 treatmentSecondary outcomes
1
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 treatment2
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 months3
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 months4
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 monthsSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: