RecruitingPhase 2NCT06829355

"Thymalfasin Immunotherapy Study with Triple Regimen in Advanced MSS/pMMR Colorectal Cancer"

Efficacy and Safety Study of Thymalfasin in Combination with Targeted Immunotherapy (Regorafenib and Tislelizumab) in Patients with Advanced PMMR/MSS Colorectal Cancer Who Failed Standard of Care: a Multicenter, Open-label, Randomized, Controlled Clinical Study

Sponsor

Beijing Friendship Hospital

Enrollment

52 participants

Start Date

Feb 11, 2025

Study Type

INTERVENTIONAL

Conditions

MCRC

Summary

This is a multicenter, open-label, prospective, randomized controlled Phase II clinical study. All eligible subjects will be randomly assigned in a 1:1 ratio to either the triple therapy group or the double therapy group. Triple therapy group: Subjects will receive Thymalfasin in combination with Regorafenib and Tislelizumab until iCPD is achieved per iRECIST (progressive disease (PD) per iRECIST), or until an intolerable toxicity occurs; Double therapy group: Subjects will receive Regorafenib and Tislelizumab until iCPD is achieved per iRECIST (PD per iRECIST), or until an intolerable toxicity occurs.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of three treatments — thymalfasin (an immune-boosting drug), a chemotherapy doublet, and fruquintinib (a targeted anti-cancer drug) — for people with advanced colorectal cancer that is classified as MSS/pMMR. This subtype of colorectal cancer typically does not respond well to standard immunotherapy, and this study aims to find a new approach. **You may be eligible if...** - You are between 18 and 75 years old - You have advanced or metastatic colorectal adenocarcinoma confirmed by biopsy - Your tumor has been tested and is MSS (microsatellite stable) or pMMR (mismatch repair proficient) — a specific molecular subtype - You have already received at least two prior lines of standard chemotherapy that are no longer working - You have at least one measurable tumor on scans - Your expected survival is at least 3 months - You are in good physical condition (ECOG score 0–1) **You may NOT be eligible if...** - Your colorectal cancer is MSI-high (a different molecular subtype treated differently) - You have serious organ problems (heart, liver, kidney, or blood) - You have active autoimmune conditions - You are pregnant or breastfeeding 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

DRUGThymalfasin (Thymosin alpha 1, Ta1)

Thymalfasin: 4.8 mg, administered subcutaneously twice weekly.

DRUGRegorafenib (BAY 73-4506)

Regorafenib: Start at 80 mg once daily, orally, taken at a fixed time for 2 consecutive weeks and then stopped for 1 week. If the patient tolerates it well, increase to 120 mg/d in Cycle 2.

DRUGTislelizumab (BGB-A317)

Tislelizumab: 200 mg, iv.gtt, single infusion, 21 days as a cycle, Day 1.

Locations(1)

Beijing Friendship Hospital, Capital Medical University

Beijing, China, China

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NCT06829355

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