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The study was divided into two dose groups, T3011 3×10\^8 plaque forming unit(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.

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.

T3011 hepatic artery infusion

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

toripalimab

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

regorafenib

Shuhui Song, bachelor

Zhenning Wang, MD

Funan Liu, MD

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.

This trial is a prospective, open-label, investigator-initiated clinical study in patients with liver metastasis from colorectal cancer, aiming to evaluate the safety and efficacy of T3011 herpes virus injection alone or in combination with toripalimab and regorafenib in patients with liver metastasis from colorectal cancer. In this study, the lead-in period of T3011 and the combination therapy period were designed, and the 3+3 dose escalation design was carried out in the lead-in period.

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

A Clinical Study to Evaluate the Safety and Efficacy of Herpes Virus T3011 Injection in Combination With Toripalimab and Regorafenib in Patients With Liver Metastases From Colorectal Cancer

An adverse event that emerges during treatment, having been absent pretreatment, or worsens relative to the pretreatment state.

Objective response rate (ORR) as assessed by the investigators

The time from the start of treatment to death for any cause

The time from the start of treatment to progress diease or death for any cause

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Clinical Study of T3011 in Combination With Toripalimab and Regorafenib in Patients With Colorectal Cancer	NCT06283303	Colorectal Canc...	T3011 hepatic a... toripalimab regorafenib	18 Years -	China Medical University, China
A Clinical Study of T3011 in Combination With Toripalimab and Regorafenib in Patients With Colorectal Cancer	NCT06283303	Colorectal Canc...	T3011 hepatic a... toripalimab regorafenib	18 Years -	China Medical University, China

Spots Global Cancer Trial Database for t3011 hepatic artery infusion