Induction Chemotherapy Combined With Neoadjuvant Immunotherapy for MSS Colon Cancer

PHASE2RecruitingINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

August 31, 2023

Primary Completion Date

August 31, 2025

Study Completion Date

August 31, 2030

Conditions
Colon Neoplasm
Interventions
DRUG

Oxaliplatin

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.

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 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-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.

DRUG

Clostridium 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.

PROCEDURE

Colectomy

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.

Trial Locations (1)

310000

RECRUITING

Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou

All Listed Sponsors
lead

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER