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Thymosin-alpha-1

Thymalfasin, Zadaxin, Thymosin α1

Quick Stats
Studies 759
Trials 63
Recruiting PHASE2 INTERVENTIONAL NCT06829355

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

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief 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.

Detailed Description

Assuming the following hypotheses: H0: The mPFS of the test group minus the mPFS of the control group equals 0 H1: The mPFS of the test group minus the mPFS of the control group does not equal 0 Assuming an mPFS of 5.0 months for the test group and 1.8 months for the control group, with a two-sided alpha level of 0.05 and 80% power, at least 32 events need to be observed. Within a 9-month enrollment period and a total study duration of 15 months, 44 subjects need to be enrolled to achieve this. Considering an additional dropout rate of 15%, 26 subjects per group are required, totaling 52 subjects (using PASS 2023 Log-rank procedure). Enrollment sites: Beijing Friendship Hospital, Capital Medical University, Peking Union Medical College Hospital, Peking University People's Hospital. Allocation of enrollment across sites: Each site will compete for enrollment, with each site enrolling no less than 14 subjects. 1. 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. 2. Tislelizumab: 200 mg, iv.gtt, single infusion, 21 days as a cycle, Day 1. 3. Thymalfasin: 4.8 mg, administered subcutaneously twice weekly. Treatment will continue until disease progression or until an intolerable adverse reaction occurs that does not resolve despite dose modification.

Interventions

Name: Thymalfasin (Thymosin alpha 1, Ta1)
Type: DRUG
Description: Thymalfasin: 4.8 mg, administered subcutaneously twice weekly.
Name: Regorafenib (BAY 73-4506)
Type: DRUG
Description: 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.
Name: Tislelizumab (BGB-A317)
Type: DRUG
Description: Tislelizumab: 200 mg, iv.gtt, single infusion, 21 days as a cycle, Day 1.

Primary Outcomes

Measure: Progression-free survival (PFS)
TimeFrame: 48 WEEKS
Description: Time from day of randomization to the date of documented tumor progression or death due to any cause

Trial Information

NCT ID

NCT06829355

Status

Recruiting

Study Type

INTERVENTIONAL

Phases

PHASE2

Sponsor

Beijing Friendship Hospital

Last Updated

December 15, 2025