P-CAMCO: Maintenance Anti-PD-1 Monoclonal Antibody + Capecitabine to Treat Metastatic Colorectal Cancer

Sponsor

Yanhong Deng (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05360277

Collaborator

(none)

Enrollment

Arm

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Surgery with integrated treatment for metastatic colorectal cancer (mCRC) has created a new clinical setting known as mCRC with no evidence of disease (NED). However, these patients have a high risk of developing persistent cancer. This study aimed to investigate the efficacy and safety of anti-PD-1 monoclonal antibody combined with capecitabine as a maintenance treatment for patients with mCRC-NED.

Condition or Disease	Intervention/Treatment	Phase
Metastatic Colorectal Cancer	Drug: Anti-PD-1 Monoclonal Antibody + Capecitabine	Phase 2

Detailed Description

This was a single-center, single-arm, phase II clinical trial. Patients who underwent synchronously or staged removal of primary and metastatic lesions, achieving NED, and histologically confirmed colorectal adenocarcinoma were recruited in this trial. The anti-PD-1 monoclonal antibody was given at a dose of 200 mg every 3 weeks. Capecitabine was given at a dose of 850 mg/m2 twice a day by mouth, 2 weeks on/ 1 week off, for 1 year after completion of perioperative chemotherapy. The primary endpoint was disease-free survival (DFS). Secondary endpoints included overall survival (OS) and adverse events. This study will provide novel data on the efficacy and safety profile of the combination of anti-PD-1 monoclonal antibody and capecitabine in patients with mCRC-NED. If the primary endpoint of this study is met, extensive phase III studies further assessing this strategy will be recommended.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Phase II Study of Maintenance Anti-PD-1 Monoclonal Antibody Combined With Capecitabine to Treat Metastatic Colorectal Cancer With No Evidence of Disease

Anticipated Study Start Date :

Aug 1, 2022

Anticipated Primary Completion Date :

Aug 1, 2026

Anticipated Study Completion Date :

Aug 1, 2029

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Anti-PD-1 Monoclonal Antibody + Capecitabine Anti-PD-1 Monoclonal Antibody 200mg every 3 weeks, or 1 year after completion of perioperative chemotherapy. Capecitabine was given at a dose of 1000 mg/m2 twice a day by mouth, 2 weeks on/ 1 week off, for 1 year after completion of perioperative chemotherapy.	Drug: Anti-PD-1 Monoclonal Antibody + Capecitabine Anti-PD-1 Monoclonal Antibody 200mg iv every 3 weeks, for 1 year after completion of perioperative chemotherapy. Capecitabine was given at a dose of 1000 mg/m2 twice a day by mouth, 2 weeks on/ 1 week off, for 1 year after completion of perioperative chemotherapy.

Arm

Intervention/Treatment

Experimental: Anti-PD-1 Monoclonal Antibody + Capecitabine

Anti-PD-1 Monoclonal Antibody 200mg every 3 weeks, or 1 year after completion of perioperative chemotherapy. Capecitabine was given at a dose of 1000 mg/m2 twice a day by mouth, 2 weeks on/ 1 week off, for 1 year after completion of perioperative chemotherapy.

Drug: Anti-PD-1 Monoclonal Antibody + Capecitabine

Anti-PD-1 Monoclonal Antibody 200mg iv every 3 weeks, for 1 year after completion of perioperative chemotherapy. Capecitabine was given at a dose of 1000 mg/m2 twice a day by mouth, 2 weeks on/ 1 week off, for 1 year after completion of perioperative chemotherapy.

Outcome Measures

Primary Outcome Measures

Disease-free survival [36 months]
The time from NED to the first occurrence of any of the following events: local relapse, distant metastasis, or death from any cause.

Secondary Outcome Measures

Overall survival [60 months]
The time from NED to death from any cause
Adverse events [60 months]
Side effect of both agents

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age ≥ 20 years, < 80 years
Written informed consent
Histologically or cytologically confirmed CRC
Surgery with integrated treatment for metastatic colorectal cancer (mCRC) and achieved a statute of no evidence of disease (NED), as determined by a multidisciplinary tumor board.
cytoreduction surgery achieves CC0 (no visible residual tumor) if there is peritoneal metastasis
No previous chemotherapy
Synchronous or metachronous metastatic disease: maximum of two distant organs or regions involved
Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
Adequate hematologic and organ function

Exclusion Criteria:

Presence of any other active cancer
Presence of active infections requiring antibiotics
History of active autoimmune disease requiring systemic treatment

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Yanhong Deng

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yanhong Deng, Professer, Sun Yat-sen University

ClinicalTrials.gov Identifier:

NCT05360277

Other Study ID Numbers:

CSWOG-C02
GIHSYSU-24

First Posted:

May 4, 2022

Last Update Posted:

May 4, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Colorectal Neoplasms

Capecitabine

Antibodies

Antibodies, Monoclonal

Study Results

No Results Posted as of May 4, 2022