MedTrace Logo

The Safety and Efficacy of HAIC+Tislelizumab+Regorafenib in Patients With Colorectal Liver Metastases

NCT05877001 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2023-05-26

No results posted yet for this study

Summary

Tislelizumab is an anti-PD-1 monoclonal antibody with high binding affinity for PD-1 and with minimized Fcγ receptor binding on macrophages. Regorafenib has been approved in mCRC by CFDA. Hepatic arterial infusion chemotherapy has a high local control rate for liver metastases. NCCN guidelines and several expert consensus recommend that regional hepatic arterial infusion chemotherapy can be considered as a "rescue treatment" for patients with colorectal cancer liver metastases who fail to receive first-line or second-line systemic chemotherapy, which can significantly prolong the overall survival of patients.

Conditions

  • Colorectal Liver Metastases

Interventions

DRUG

Tislelizumab

200mg, IV, Q3W

DRUG

Regorafenib

80 mg once daily for the first 3 weeks of each 4-week cycle

OTHER

HAIC

OXA 85mg/m2 IA 0-4h +5-Fu 2000mg/m2 IA 4-48h，CF 200mg/m2 IV 2-4h， Q3W

Sponsors & Collaborators

  • Peking University Cancer Hospital & Institute

    lead OTHER

Principal Investigators

  • Xu Zhu, MD · Peking University Cancer Hospital & Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-30
Primary Completion
2024-07-30
Completion
2025-03-01

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

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 NCT05877001 on ClinicalTrials.gov