RecruitingPhase 2NCT06002789

Safety and Efficacy of PD-1 ± mFOLFOX6 Neoadjuvant Therapy in Local Advanced sMPCC

Safety and Efficacy of PD-1 Monoclonal Antibody With or Without mFOLFOX6 Neoadjuvant Therapy in Patients With Local Advanced Deficient Mismatch Repair/Microsatellite Instability-high Synchronous Multiple Primary Colorectal Cancer (sMPCC)


Sponsor

Sixth Affiliated Hospital, Sun Yat-sen University

Enrollment

17 participants

Start Date

May 1, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

At present, radical resection ± preoperative neoadjuvant chemotherapy for colorectal cancer is still the standard comprehensive treatment. In recent years, immunotherapy of PD-1 monoclonal antibody has a significant effect in the second-line/first-line treatment of dMMR/MSI-H advanced colorectal cancer and the neoadjuvant treatment of early colorectal cancer. Synchronous multiple primary colorectal cancer (sMPCC) is a relatively rare type of colorectal cancer (CRC) that refers to the simultaneous occurrence of 2 or more independent primary malignancies in the colon or rectum. The recent large-scale, single-center retrospective study of the investigator showed that compared with single primary colorectal cancer (SPCRC)patients, the incidence of dMMR/MSI-H was significantly higher in sMPCC patients. Besides, a certain proportion of sMPCC patients could both have MSI and MSS tumors at the same time. There is no standard regimen for this patients so far. This study intends to treat the MSI-H/MSS (dMMR/pMMR) mixed sMPCC patients with combination of mFOLFOX6+PD-1 monoclonal antibody neoadjuvant therapy, and treat the all-MSI-H (dMMR) sMPCC patients with single-drug PD-1 monoclonal antibody neoadjuvant therapy. Given the current gaps in the guideline, the investigator intends to take the lead in carrying out this open, multi-center, prospective clinical phase II study. This study might provide a clinical evidence for individual treatment of sMPCC patients, in preserving the functions and organs to the greatest extent.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study tests immunotherapy (PD-1 checkpoint inhibitor), with or without chemotherapy (mFOLFOX6), as a pre-surgery treatment in patients with locally advanced simultaneous multiple primary colorectal cancer (a rare situation where multiple separate colorectal cancers are present at the same time) that has a specific genetic marker called MSI-H or dMMR. **You may be eligible if...** - You have been diagnosed with simultaneous multiple primary colorectal cancer (multiple separate tumors in the colon or rectum at the same time), confirmed by biopsy - At least one tumor tests positive for dMMR (deficient mismatch repair) or MSI-H (microsatellite instability-high) — a genetic marker your doctor can check - Your cancer is locally advanced (has grown into surrounding tissue or nearby lymph nodes) but has not spread to distant organs (stage T3-4, no distant metastasis) **You may NOT be eligible if...** - Your tumor does not have the MSI-H or dMMR marker - Your cancer has already spread to distant organs - You have a single primary colorectal tumor rather than multiple simultaneous ones 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

DRUGMSI-H/MSS (dMMR/pMMR) mixed sMPCC: combination of mFOLFOX6+PD-1 monoclonal antibody neoadjuvant therapy

For MSI-H/MSS (dMMR/pMMR) mixed sMPCC, a combination of neoadjuvant chemotherapy with mFOLFOX6 and immunotherapy with PD-1 monoclonal antibody are applied.

DRUGAll-MSI-H (dMMR) sMPCC: single-drug PD-1 monoclonal antibody neoadjuvant therapy

For all-MSI-H (dMMR) sMPCC, single-drug PD-1 monoclonal antibody immunotherapy is applied.


Locations(1)

The Sixth Affiliated Hospital, Sun Yatsen University

Guangzhou, Guangdong, China

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NCT06002789


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