Maintenance Tislelizumab + Capecitabine to Treat Metastatic Colorectal Cancer (CAMCO2)

Maintenance Tislelizumab Combined With Capecitabine to Treat Metastatic Colorectal Cancer With No Evidence of Disease

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 Tislelizumab combined with capecitabine as a maintenance treatment for patients with mCRC-NED.

Study Overview

• Status: Recruiting
• Conditions: Metastatic Colorectal Cancer，NED
• Intervention / Treatment: Other: Best supportive care; Drug: Tislelizumab + Capecitabine

Detailed Description

This is a Phase 2, randomized, open-label, single-center study designed to compare the efficacy and safety of tislelizumab+ capecitabine versus best-supported care as a first-line maintenance treatment in participants with mCRC-NED.

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 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 tislelizumab and capecitabine in patients with mCRC-NED.

• Study Type: Interventional
• Enrollment (Estimated): 52
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510655
      • Recruiting
      • Gastrointestinal Hospital, Sun Yat-sen University
      • Contact: Yanhong Deng, MD; Phone Number: 008613925106525; Email: 13925106525@163.com
      • Principal Investigator: Yanhong Deng, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age ≥ 20 years, < 80 years
2. Written informed consent
3. Histologically or cytologically confirmed CRC
4. 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.
5. cytoreduction surgery achieves CC0 (no visible residual tumor) if there is peritoneal metastasis
6. No previous chemotherapy
7. Synchronous or metachronous metastatic disease: maximum of two distant organs or regions involved
8. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
9. Adequate hematologic and organ function

Exclusion Criteria:

1. Presence of any other active cancer
2. Presence of active infections requiring antibiotics
3. History of active autoimmune disease requiring systemic treatment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tislelizumab + Capecitabine; Tislelizumab 200mg every 3 weeks, or 1 year after completion of perioperative chemotherapy. 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.	Drug: Tislelizumab + Capecitabine; Tislelizumab 200mg iv every 3 weeks, for 1 year after completion of perioperative chemotherapy. 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.
Active Comparator: Best supportive care; Best supportive care was the standard care in this setting.	Other: Best supportive care; Best supportive care

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	The time from NED to death from any cause	60 months
Adverse events	Side effect of both agents	60 months

Collaborators and Investigators

• Sponsor: Yanhong Deng

Study record dates

Study Major Dates

• Study Start (Actual): August 22, 2023
• Primary Completion (Estimated): February 28, 2025
• Study Completion (Estimated): November 30, 2027

Study Registration Dates

• First Submitted: April 30, 2022
• First Submitted That Met QC Criteria: April 30, 2022
• First Posted (Actual): May 4, 2022

Study Record Updates

• Last Update Posted (Actual): December 12, 2023
• Last Update Submitted That Met QC Criteria: December 5, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Metastatic Colorectal Cancer，NED
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Antineoplastic Agents, Immunological; Capecitabine; Tislelizumab
• Other Study ID Numbers: CSWOG-C02; GIHSYSU-24 (Other Identifier: The Sixth Affiliated Hospital of Sun Yat-sen University)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No