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

NCT05894837 | Unknown Phase 2 DMC

• 1 other identifier: 2023-034
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Colorectal Cancer; Liver Metastases

Keywords

Colorectal Cancer; Regorafenib; hepatic artery bicarbonate infusion; Serplulimab

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate

  Objective Response Rate was defined as the proportion of patients with a best objective response of complete response (CR) or partial response (PR) according to RECIST criteria (version 1.1).

  From Baseline to disease progress, up to 18 months

Secondary Outcomes (3)

• Adverse Events and Serious Adverse Events

  From Baseline to primary completion date, about 2 years

• Progression free survival

  From Baseline to primary completion date, about 2 years

• Overal survival

  From Baseline to primary completion date, about 5 years

Study Arms (1)

Serplulimab in combination with Regorafenib and hepatic artery bicarbonate infusion

EXPERIMENTAL

Serplulimab: once every two weeks; Regorafenib: from the first day to the 21th day; hepatic artery bicarbonate infusion: once every four weeks

Drug: Serplulimab+Regorafenib; Drug: Hepatic Artery Bicarbonate Infusion

Interventions

Serplulimab+Regorafenib DRUG

Serplulimab: once every two weeks; Regorafenib: from the first day to the 21st day

Serplulimab in combination with Regorafenib and hepatic artery bicarbonate infusion

Hepatic Artery Bicarbonate Infusion DRUG

hepatic artery bicarbonate infusion: once every four weeks

Serplulimab in combination with Regorafenib and hepatic artery bicarbonate infusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 or above, male or female;
• 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;
• At least 1 measurable intrahepatic lesion;
• Child-Pugh liver function rating: A or good B (≤7 points) ;
• No local treatment including radiotherapy, surgical excision and ablation was performed before interventional therapy;
• No other malignant tumors;
• ECOG score within one week before enrollment: 0-1;
• Predicted survival ≥24 weeks;
• 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；
• The subjects voluntarily joined the study, signed the informed consent, had good compliance, and cooperated with follow-up；

You may not qualify if:

• There is a contraindication of anti-PD-1 monoclonal antibody therapy;
• With other uncured malignancies, except for cured basal cell carcinoma of the skin and cervical carcinoma in situ;
• Patients who are preparing for an organ transplant or have had an organ transplant in the past；
• Ascites with clinical symptoms that require therapeutic abdominal puncture or drainage, or Child-Pugh score \> 2；
• 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；
• 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；
• Having multiple factors that affect oral medication (such as inability to swallow, chronic diarrhea, and intestinal obstruction, which significantly affects drug administration and absorption)；
• 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；
• Had an abdominal fistula, gastrointestinal perforation, or abdominal abscess in the 28 days prior to joining the study；
• 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；
• Patients with central nervous system metastases or known brain metastases；
• Patients with past and current objective evidence of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, and severe impairment of lung function；
• Urine routine showed urine protein ≥++ or confirmed 24 hours urine protein quantity \> 1.0 g；
• Severe thyroid disease cannot be controlled by treatment；
• Rheumatic or autoimmune diseases, and immunosuppressant or high-dose hormone therapy after organ transplantation；

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

the Second Affiliated Hospital of Medical College of Zhejiang University

Hangzhou, Zhejiang, 310000, China

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Ying Yuan

  The Second Affiliated Hospital of Medical College of Zhejiang University

  STUDY CHAIR

Central Study Contacts

Shanshan Weng

CONTACT

+86-13758118823; 2310053@zju.edu.cn

Ying Yuan

CONTACT

+86-13858193601; yuanying1999@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2023
• First Posted: June 8, 2023
• Study Start: June 1, 2023
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2025
• Last Updated: June 8, 2023

Record last verified: 2023-05

Locations

CN (1)