RecruitingPhase 2NCT06254521

The Effects of Neoadjuvant Tislelizumab Combined With Chemotherapy in Locally Advanced MSS Rectal Cancer

Neoadjuvant Treatment of Locally Advanced MSS Rectal Cancer With Tislelizumab Combined With CAPOX Regimen: a Prospective, Single-arm, Single-center, Exploratory Phase II Clinical Study


Sponsor

First Affiliated Hospital of Guangxi Medical University

Enrollment

60 participants

Start Date

Feb 22, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This study aims to elucidate the effects of neoadjuvant Tislelizumab combined with chemotherapy in locally advanced MSS rectal cancer.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether adding the immunotherapy drug tislelizumab to standard pre-operative chemotherapy improves outcomes in patients with a specific type of rectal cancer called MSS (microsatellite stable) — a type that typically does not respond well to immunotherapy on its own. The treatment is given before surgery to try to shrink the tumor. **You may be eligible if...** - You are aged 18–70 with confirmed MSS rectal cancer that has not spread to distant organs - Your tumor is located within 12 cm of the anal opening - Imaging shows your tumor has grown into surrounding tissues or spread to nearby lymph nodes (T3-4 or N+) - You have not received any prior treatment for this cancer - Your general health status is good (ECOG 0–1) **You may NOT be eligible if...** - Your cancer has spread to distant organs (metastatic) - You have received prior anti-cancer therapy - You have active autoimmune disease or other conditions that make immunotherapy unsafe - Your organ function is inadequate 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

DRUGTislelizumab combined with chemotherapy

Drug: Oxaliplatin Oxaliplatin 130mg/m2 for chemotherapy on Day 1 every 3 weeks and repeat for 2 or 4 cycles. The dose reduction protocol for oxaliplatin-induced toxicity was implemented according to the report in BJC (2018) 118:1322-1328. Drug: Capecitabine Oral Capecitabine 1000 mg/m2 twice daily combined with oxaliplatin chemotherapy from Day 1 to Day 14 every 3 weeks and repeat for 2 or 4 cycles. The dose reduction protocol for capecitabine-induced toxicity was implemented according to the report in BJC (2018) 118:1322-1328. Drug: Anti-PD-1 Monoclonal Antibody 200 mg on Day 1 every 3 weeks and repeat for 2 or 4 cycles. The incidence of adverse events with Anti-PD-1 Monoclonal Antibodies is relatively low. The PD-1 monoclonal antibody (Tislelizumab) dose adjustment was implemented according to the prescribing information. Other Names: Tislelizumab Procedure: Colectomy The specific surgical approach, whether it be laparoscopic


Locations(1)

The First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, China

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NCT06254521


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