RecruitingPhase 3NCT05768503

Comparing Chidamide+Sintilimab+Bev With Standard Second-line FOLFIRI+Bev in Advanced MSS/pMMR mCRC

Chidamide+Sintilimab+Bevacizumab Versus Standard Second-Line Therapy of FOLFIRI+Bevacizumab in Subjects With Advanced Microsatellite Stable (MSS/pMMR) Colorectal Cancer Who Have Failed Oxaliplatin-Containing First-Line Therapy

Sponsor

Sun Yat-sen University

Enrollment

176 participants

Start Date

Mar 1, 2023

Study Type

INTERVENTIONAL

Conditions

Metastatic Microsatellite-stable Colorectal Cancer

Summary

This is a randomized, controlled, multicenter phase Ⅲ study to evaluate the therapeutic efficacy and safety of chidamide + sintilimab + bevacizumab versus standard second-line FOLFIRI + bevacizumab therapy in subjects with advanced microsatellite stable colorectal cancer who have failed first-line oxaliplatin-containing standard therapy. The primary purpose is to compare the progression-free survival (PFS) of chidamide + sintilimab + bevacizumab versus standard second-line FOLFIRI + bevacizumab therapy for colorectal cancer, with a planned enrollment of 176 subjects with advanced microsatellite stable colorectal cancer who have failed first-line oxaliplatin-containing standard therapy.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new three-drug combination — chidamide (an epigenetic drug), sintilimab (an immunotherapy), and bevacizumab (a drug that cuts off tumor blood supply) — as second-line treatment for advanced colorectal cancer that lacks a certain genetic marker (MSS/pMMR), which typically doesn't respond well to immunotherapy alone. **You may be eligible if...** - You have confirmed locally advanced or metastatic colorectal adenocarcinoma - Your tumor is MSS (microsatellite stable) or pMMR (mismatch repair proficient), confirmed by lab testing - Your cancer stopped responding to or progressed on first-line oxaliplatin-based chemotherapy **You may NOT be eligible if...** - Your tumor is MSI-high (has specific genetic instability markers) - You have not received prior first-line chemotherapy - You have other cancer types (e.g., mixed adenosquamous carcinoma) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGExperimental drug

The treatment option for the chidamide + sintilimab + bevacizumab is 200 mg of sintilimab IV Drip Q3W, 30 mg of chidamide PO BIW, and bevacizumab 7.5 mg/kg IV Drip Q3W until loss of clinical benefit or development of intolerable toxicity (whichever occurs first), with a maximum treatment duration of 2 years.

DRUGControl Rx

The treatment option for the standard second-line FOLFIRI + bevacizumab therapy group is bevacizumab 5 mg/kg IV Drip Q2W, irinotecan 180 mg/m2 IV Drip Q2W, calcium folinate 400 mg/m2 IV Q2W or calcium levofolinate 200 mg/m2 IV Drip Q2W, 5-fluorouracil 400 mg/m2 IV +2400 mg/m2 CIV (infusion 46-48 hr) Q2W until loss of clinical benefit or development of intolerable toxicity (whichever occurs first), with a maximum treatment duration of 2 years.

Locations(12)

Anhui Provincial Cancer Hospital

Hefei, Anhui, China

The First People's Hospital of Foshan

Foshan, Guangdong, China

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

The Third Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

The First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, China

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

Henan Cancer Hospital

Zhengzhou, Henan, China

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

West China Hospital of Sichuan University

Chengdu, Sichuan, China

The Second Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, China

The First Affiliated Hospital of Zhejiang University College of Medicine

Hangzhou, Zhejiang, China

View Full Details on ClinicalTrials.gov

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