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Cetuximab in Combination With Anti-PD-1 and mFOLFOX Treat For RAS/BRAF wt Right-Sided Colon Cancer

NCT05468177 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2022-07-21

No results posted yet for this study

Summary

We plan to evaluate the efficacy and safety of cetuximab combined with anti-PD-1 and mFOLFOX6 in the treatment of RAS/BRAF WT locally advanced or metastatic right colon cancer

Conditions

  • Colonic Neoplasms

Interventions

COMBINATION_PRODUCT

neoadjuvant chemotherapy

Cetuximab: 500mg/m2,day1, every 2 weeks. mFOLFOX: oxaliplatin 85mg/m2, day 1;LV 400mg/m2, day 1;5-FU 400mg/m2, day 1, then 1200mg/ (m2•d) ×2days(total 2400mg/m2, infusion 46-48h) (every 2 weeks). Anti-PD-1(Sintilimab Injection):200mg every 3 weeks. Surgery will be performed after 4 cycles for locally advanced or initially resectable metastatic right colon cancer.If the initial unresectable metastatic right colon cancer were converted into resectable metastases, and surgery will be performed. Patients who failed to convert after 6 cycles of treatment will be withdrawn from the study.Cetuximab +mFOLFOX was treat for 8 cycles, and Anti-PD-1 was treated for one year in the perioperation period unless disease progression, toxicity intolerance, initiation of new anti-tumor therapy.

Sponsors & Collaborators

  • Huangshi Central Hospital

    collaborator OTHER

  • Central Hospital of Xiaogan

    collaborator OTHER

  • Ezhou Central Hospital

    collaborator UNKNOWN

  • Jingzhou Central Hospital

    collaborator OTHER

  • Tongji Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-01
Primary Completion
2023-06-30
Completion
2025-06-30

Countries

  • China

Study Locations

More Related Trials

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 NCT05468177 on ClinicalTrials.gov