NCT05360277

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for phase_2

Timeline
19mo left

Started Aug 2023

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress63%
Aug 2023Nov 2027

First Submitted

Initial submission to the registry

April 30, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 4, 2022

Completed
1.3 years until next milestone

Study Start

First participant enrolled

August 22, 2023

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2025

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2027

Expected
Last Updated

December 12, 2023

Status Verified

December 1, 2023

Enrollment Period

1.5 years

First QC Date

April 30, 2022

Last Update Submit

December 5, 2023

Conditions

Metastatic Colorectal Cancer，NED

Keywords

Metastatic Colorectal Cancer，NED

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Overall survival

    60 months

  • Adverse events

    60 months

Study Arms (2)

Tislelizumab + Capecitabine

EXPERIMENTAL

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

Best supportive care

ACTIVE COMPARATOR

Best supportive care was the standard care in this setting.

Other: Best supportive care

Interventions

Tislelizumab + CapecitabineDRUG

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.

Tislelizumab + Capecitabine
Best supportive careOTHER

Best supportive care

Best supportive care

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gastrointestinal Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510655, China

RECRUITING

MeSH Terms

Interventions

tislelizumabCapecitabine

Intervention Hierarchy (Ancestors)

DeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professer

Study Record Dates

First Submitted

April 30, 2022

First Posted

May 4, 2022

Study Start

August 22, 2023

Primary Completion

February 28, 2025

Study Completion (Estimated)

November 30, 2027

Last Updated

December 12, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)