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A Clinical Study of T3011 in Combination With Toripalimab and Regorafenib in Patients With Colorectal Cancer

NCT06283303 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2024-02-29

No results posted yet for this study

Summary

This is a phase I, open-label clinical study of T3011 in combination with Toraplizumab and Regorafenib in patients with liver metastases from colorectal cancer.

Conditions

  • Colorectal Cancer Metastatic

Interventions

BIOLOGICAL

T3011 hepatic artery infusion

The study was divided into two dose groups, T3011 3×10\^8 PFU/time (HAI) and T3011 1×10\^9 PFU/time (HAI), with a 3+3 dose escalation design. After the completion of the lead-in period, the patient entered the combination therapy period（combination therapy with T3011 hepatic artery infusion , Regorafenib and Toripalimab）,and the dosage of T3011 was determined according to the safety observation results of the lead-in period, the dose of toripalimab was 80mg intravenously, and regorafenib was 80mg orally once a day.

DRUG

toripalimab

The combination therapy period: toripalimab, 80mg intravenous ,D2 and D16, 4 weeks per cycle

DRUG

regorafenib

The combination therapy period: regorafenib ,80mg orally once a day, D1-D21,4 weeks per cycle

Sponsors & Collaborators

  • Immvira Co., Limited

    collaborator UNKNOWN

  • China Medical University, China

    lead OTHER

Principal Investigators

  • Zhenning Wang, MD · The First Affiliated Hospital of China Medical Univeristy

  • Funan Liu, MD · The First Affiliated Hospital of China Medical Univeristy

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-02
Primary Completion
2025-11-30
Completion
2025-11-30

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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 NCT06283303 on ClinicalTrials.gov