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Neoadjuvant Chemoradiotherapy Combined With PD-1 Inhibitor and Thymalfasin for pMMR/MSS Locally Advanced Mid-low Rectal Cancer | Clinical Trials | Clareo Health

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Neoadjuvant Chemoradiotherapy Combined With PD-1 Inhibitor and Thymalfasin for pMMR/MSS Locally Advanced Mid-low Rectal Cancer

Efficacy and Safety of Neoadjuvant Chemoradiotherapy Combined With PD-1 Inhibitor and Thymalfasin in pMMR/MSS Locally Advanced Middle and Low Rectal Cancer: An Open, Multi-center, Prospective, Single-arm Phase II Clinical Study

NCT06056804•Beijing Friendship Hospital

View on ClinicalTrials.gov

Summary

This is an open, prospective, multi-center, single-arm phase II clinical study assessing the efficacy and safety of neoadjuvant chemoradiotherapy combined with PD-1 inhibitor and thymalfasin in patients with pMMR/MSS locally advanced middle and low rectal cancer.

Detailed Description

This study is an open, prospective, multi-center, single-arm phase II clinical study. In this study, patients with pMMR/MSS locally advanced middle and low rectal cancer were selected as the subjects and treated with neoadjuvant treatment protocol of long-course concurrent chemoradiotherapy combined with PD-1 monoclonal antibody and thymalfasin. The primary endpoint of the study was complete response (CR) rate. The secondary end points included treatment-related adverse events (TRAEs) rate, 30-day incidence of postoperative complications, objective response rate (ORR), 3-year disease-free survival (DFS) rate, Neoadjuvant rectal cancer (NAR) score, R0 resection rate, and anal preservation rate.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Patients who were fully informed of the study and voluntarily signed the informed consent form;
•2. Patients with rectal cancers must satisfied all the following conditions:
•1\) Stage II/III LARC (cT3-4aN0M0 and cT1-4aN1-2M0); 2) Tumor distal located ≤ 10 cm from anal verge (MRI diagnosed); 3) pMMR or MSS confirmed by immunohistochemistry or genetic test. 3.Patients regardless of gender with aged ≥18 years and ECOG score of 0 or 1; 4. Physical and viscera function of patients can withstand major abdominal surgery; 5.Patients are willing and able to follow the study protocol during the study 6.Patients give consent to the use of pathological specimens for study 7.Within 28 days prior to enrolment, we must confirm a negative serological pregnancy test for child-bearing age women and they agree to use effective contraception for the duration of drug use and for 60 days after the last dose.

Exclusion Criteria

•1. Patients have a present or previous active malignancy except the diagnosis of rectal cancer this time;
•2. Patients underwent major surgery within 4 weeks prior to study treatment;
•3. Patients have any condition affects the absorption of capecitabine through gastrointestinal tract;
•4. Patients have severe uncontrolled recurrent infections, or other severe uncontrolled concomitant diseases;
•5. Patients who are allergic to any of the ingredients under study;
•6. Patients with severe concomitant diseases with estimated survival ≤ 5 years;
•7. Patients with present or previous moderate or severe liver and kidney damage presently or previously;
•8. Patients have received other study medications or any immunotherapy currently or in the past;
•9. Patients preparing for or previously received organ or bone marrow transplant;
•10. Patients who received immunosuppressive or systemic hormone therapy for immunosuppressive purposes within 1 month prior to the initiation of study therapy;
+14 more criteria

Locations (2)

Beijing Friendship Hospital,Capital Medical University

Beijing, China

Peking Union Medical College Hospital

Beijing, China

Key Dates

Start Date

January 3, 2024

Primary Completion Date

December 1, 2024

Completion Date

July 1, 2027

Last Updated

April 2, 2025

Enrollment

ESTIMATED participants

Conditions

Locally Advanced Rectal Cancer

Interventions

capecitabine

DRUG

tislelizumab

DRUG

thymalfasin

DRUG

long-term radiotherapy

RADIATION

SMART TNT for the Conservative Management of Locally Advanced Rectal Cancer

NCT05412082

Locally Advanced Rectal Cancer

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RECRUITINGPHASE2

Node-sparing Radiotherapy Combined with Total Neoadjuvant CAPOX and Sintilimab for MSS Middle and Low Rectal Cancer

NCT06204094

Locally Advanced Rectal Cancer

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RECRUITINGPHASE2

Consolidation Versus Induction Chemotherapy in Total Neoadjuvant Therapy of Rectal Cancer With High Risk for Recurrence

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 2, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Neoadjuvant Chemoradiotherapy Combined With PD-1 Inhibitor and Thymalfasin for pMMR/MSS Locally Advanced Mid-low Rectal Cancer

Inclusion Criteria

Exclusion Criteria

SMART TNT for the Conservative Management of Locally Advanced Rectal Cancer

Node-sparing Radiotherapy Combined with Total Neoadjuvant CAPOX and Sintilimab for MSS Middle and Low Rectal Cancer

Consolidation Versus Induction Chemotherapy in Total Neoadjuvant Therapy of Rectal Cancer With High Risk for Recurrence

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Intraoperative Electron Radiotherapy in Rectal Cancer - A Feasibility Trial

GEMCAD-REVEAL STUDY - Circulating Tumor DNA as a Predictor of Relapse in Patients With Locally Advanced Rectal Cancer.