RecruitingPhase 2NCT05914389

Induction Chemotherapy Combined With Neoadjuvant Immunotherapy for MSS Colon Cancer

Induction Chemotherapy Combined With Neoadjuvant Immunotherapy for MSS Colon Cancer: a Prospective Single-center Multi-arm Open-label Randomized Phase II Study


Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Enrollment

100 participants

Start Date

Aug 1, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This study aims to elucidate the regression effects of neoadjuvant chemotherapy combined with immunotherapy and adjuvant therapy in locally advanced MSS colon cancer.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing induction chemotherapy (FOLFOX) followed by immunotherapy before surgery for colon cancer that is classified as MSS or pMMR — a type that typically does not respond well to immunotherapy alone. **You may be eligible if...** - You are 18–75 years old - You have colon cancer (not rectal cancer — tumor must be more than 12 cm from the anus) - Your cancer is confirmed MSS or pMMR type - You have not yet had surgery or treatment for this cancer - You have good organ function and performance status **You may NOT be eligible if...** - Your cancer has spread to distant organs (stage IV) - Your tumor is in the rectum (lower colon) - You have active autoimmune disease - 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

DRUGOxaliplatin

Oxaliplatin 130mg/m2 for inducing chemotherapy on Day 1 every 3 weeks and repeat for 4 cycles. The dose reduction protocol for oxaliplatin-induced toxicity was implemented according to the report in BJC (2018) 118:1322-1328.

DRUGCapecitabine

Oral Capecitabine 1000 mg/m2 twice daily combined with oxaliplatin chemotherapy from Day 1 to Day 14 every 3 weeks and repeat for 4 cycles. The dose reduction protocol for capecitabine-induced toxicity was implemented according to the report in BJC (2018) 118:1322-1328.

DRUGAnti-PD-L1 Monoclonal Antibody

The incidence of adverse events with Anti-PD-L1 Monoclonal Antibodies is relatively low. Based on phase I clinical trial data of Envafolimab, a dose reduction design was conducted to minimize the incidence of adverse events while ensuring therapeutic efficacy. In the two cohorts of the efficacy-enhancing design, a reduced dose of 100mg/0.5ml IH QW will be used for 6 weeks. The PD-L1 monoclonal antibody (Envafolimab) dose adjustment was implemented according to the prescribing information.

DRUGClostridium butyricum

Clostridium butyricum is treated with Miyarisan 588 powder, 160mg/day (4 packets/day) taken orally for a total of 6 weeks.There have been no reports of adverse reactions for Lactobacillus. There is no predetermined reduction plan.

PROCEDUREColectomy

The specific surgical approach, whether it be laparoscopic or open surgery, is determined by the surgeon. The tumor blood supply is ligated and cut at the root of the mesentery, and the margin of resection should be no less than 10cm. Complete resection of the mesocolon (CME) is performed in conjunction.


Locations(1)

Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

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NCT05914389


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