Serplulimab+Regorafenib +Hepatic Artery Bicarbonate Infusion in Patients With Colorectal Cancer and Liver Metastases

Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study ID
NCT05894837
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Serplulimab+Regorafenib — DRUG
    Serplulimab: once every two weeks; Regorafenib: from the first day to the 21st day
  • Hepatic Artery Bicarbonate Infusion — DRUG
    hepatic artery bicarbonate infusion: once every four weeks

Study Details

A single-center, single-arm, phase 2 trial of Serplulimab in combination with Regorafenib and hepatic artery bicarbonate infusion for third-line treatment in patients with colorectal cancer and liver metastases. A total of 30 patients are planned to be enrolled.

Key Dates

Start date
Jun 1, 2023
Status verified
May 2023
Primary completion
Jun 1, 2024
Completion
Jun 1, 2025

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Serplulimab in combination with Regorafenib and hepatic artery bicarbonate infusion
    Serplulimab: once every two weeks; Regorafenib: from the first day to the 21th day; hepatic artery bicarbonate infusion: once every four weeks

Primary Outcome Measure

Objective Response Rate [ Time Frame: From Baseline to disease progress, up to 18 months ]

Central Contacts

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