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Sintilimab and Chidamide in Combination With or Without IBI305 in Advanced or Metastatic pMMR/MSS Colorectal Carcinoma

NCT04724239 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2023-08-01

No results posted yet for this study

Summary

The purpose of this study is to evaluate the efficacy and safety of sintilimab and chidamide in combination with or without IBI305(bevacizumab) in patients with standard treatment failure of advanced or metastatic pMMR/MSS colorectal adenocarcinoma.

Conditions

  • Advanced Microsatellite Stable Colorectal Cancer
  • Metastatic Microsatellite-stable Colorectal Cancer

Interventions

DRUG

Sintilimab

200mg IV on Day 1 Q3W

DRUG

Chidamide

30mg PO BIW each 3-week cycle

DRUG

IBI305

7.5mg/kg IV on Day 1 Q3W

Sponsors & Collaborators

  • Sun Yat-sen University

    lead OTHER

Principal Investigators

  • Ruihua Xu, MD, PhD · Sun Yat-sen University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-11
Primary Completion
2022-07-26
Completion
2023-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04724239 on ClinicalTrials.gov