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

NCT06829355 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2025-02-17

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Thymalfasin (Thymosin alpha 1, Ta1)

Thymalfasin: 4.8 mg, administered subcutaneously twice weekly.

DRUG

Regorafenib (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.

DRUG

Tislelizumab (BGB-A317)

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

Sponsors & Collaborators

  • Peking Union Medical College Hospital

    collaborator OTHER

  • Peking University People's Hospital

    collaborator OTHER

  • Beijing Friendship Hospital

    lead OTHER

Principal Investigators

  • Zhongtao Zhang, Professor · Beijing Friendship Hospital

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
2025-02-11
Primary Completion
2025-12-31
Completion
2027-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT06829355 on ClinicalTrials.gov