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Serplulimab+Regorafenib +Hepatic Artery Bicarbonate Infusion in Patients With Colorectal Cancer and Liver Metastases | Clinical Trials | Clareo Health

UNKNOWNPHASE2

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

Serplulimab in Combination With Regorafenib and Hepatic Artery Bicarbonate Infusion for Third-line Treatment in Patients With Colorectal Cancer and Liver Metastases: a Single-center, Single-arm, Phase 2 Trial

NCT05894837•Second Affiliated Hospital, School of Medicine, Zhejiang University

View on ClinicalTrials.gov

Summary

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.

Detailed Description

This is a single-center, single-arm, phase 2 trial. Enroll 30 patients with colorectal cancer and liver metastases and failure of standard therapy. Administer serplulimab intravenously(once every two weeks)in combination with regorafenib(from the first day to the 21th day) and hepatic artery bicarbonate infusion (once every four weeks). Medication must be discontinued until disease progression, intolerable toxicity, informed consent is withdrawn, or investigator judgment is made. The primary endpoint is objective response rate (ORR), and secondary endpoints are progression-free survival (PFS), overall survival (OS), and adverse effects (AE).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age 18 or above, male or female;
•2. Patients with colorectal cancer and liver metastases who strictly conform to the clinical diagnostic criteria of "Chinese Guidelines for Diagnosis and Treatment of Colorectal Cancer (2020 Edition)" or who have been confirmed by histopathology or cytology;
•3. At least 1 measurable intrahepatic lesion;
•4. Child-Pugh liver function rating: A or good B (≤7 points) ;
•5. No local treatment including radiotherapy, surgical excision and ablation was performed before interventional therapy;
•6. No other malignant tumors;
•7. ECOG score within one week before enrollment: 0-1;
•8. Predicted survival ≥24 weeks;
•9. The major organs are functioning normally; the following criteria are met: Blood examination: a) HB≥90 g/L；b) ANC≥1.5×109/L；c) PLT≥80×109/L; Biochemical examination: a) ALB ≥29 g/L；b) ALT and AST\<5ULN；c) TBIL ≤1.5ULN；d) Creatinine≤1.5ULN；(Only one of the two measures of albumin and bilirubin in the Child-Pugh rating can be a score of 2); Thyroid function tests are within normal range；
•10. Women of childbearing age must already be using reliable contraception or have had a pregnancy test (serum or urine) with negative results within 7 days prior to inclusion and be willing to use an appropriate method of contraception during the trial period and 8 weeks after the last test drug administration；
+1 more criteria

Exclusion Criteria

•1. There is a contraindication of anti-PD-1 monoclonal antibody therapy;
•2. With other uncured malignancies, except for cured basal cell carcinoma of the skin and cervical carcinoma in situ;
•3. Patients who are preparing for an organ transplant or have had an organ transplant in the past；
•4. Ascites with clinical symptoms that require therapeutic abdominal puncture or drainage, or Child-Pugh score \> 2；
•5. Patients with high blood pressure (systolic blood pressure \> 140 mmHg, diastolic blood pressure \> 90 mmHg) who cannot be reduced to the normal range by antihypertensive medication；
•6. Patients with grade Ⅱ or above myocardial ischemia or myocardial infarction, poorly controlled arrhythmias (including QTc interval ≥450 ms for males and 470 ms for females); A history of symptomatic ischemic or hemorrhagic cerebrovascular disease；
•7. Having multiple factors that affect oral medication (such as inability to swallow, chronic diarrhea, and intestinal obstruction, which significantly affects drug administration and absorption)；
•8. Patients with a history of gastrointestinal bleeding or a definite tendency to gastrointestinal bleeding within the past 6 months, such as esophageal varicose veins with bleeding risk, locally active ulcer lesions, stool occult blood ≥ (++), should not be included in the group; If fecal occult blood (+), gastroscopy is required；
•9. Had an abdominal fistula, gastrointestinal perforation, or abdominal abscess in the 28 days prior to joining the study；
•10. Patients with abnormal coagulation function (INR \> 1.5 or prothrombin time (PT) \> ULN+4 seconds) who are prone to bleeding or are receiving thrombolytic or anticoagulant therapy；
+5 more criteria

Locations (1)

the Second Affiliated Hospital of Medical College of Zhejiang University

Hangzhou, Zhejiang, China

Key Dates

Start Date

June 1, 2023

Primary Completion Date

June 1, 2024

Completion Date

June 1, 2025

Last Updated

June 8, 2023

Enrollment

ESTIMATED participants

Conditions

Colorectal CancerLiver Metastases

Interventions

Serplulimab+Regorafenib

DRUG

Hepatic Artery Bicarbonate Infusion

DRUG

Contacts

Shanshan Weng

CONTACT

+86-13758118823 2310053@zju.edu.cn

Ying Yuan

CONTACT

+86-13858193601 yuanying1999@zju.edu.cn

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 8, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)

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Evaluation of the Safety and Efficacy of Treatment w/High Dose Melphalan Given Directly Into the Liver Followed by Treatment w/Approved Cancer Treatment or Approved Cancer Treatment Alone in Patients w/ Metastatic Colorectal Cancer w/Liver Dominant Disease