Regorafenib and Sintilimab in Combination With Electroacupuncture in MSS CRC
NCT Number: NCT06456515
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Colorectal Cancer Metastatic
Interventions: DRUG: Regorafenib and Sintilimab in combination with electroacupuncture
Sponsor: The First People's Hospital of Changzhou
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06
Completion Date: 2026-03

Summary:
The aim of this clinical trial is to find out whether Regorafenib and Sintilimab in combination with electroacupuncture works in treating participants with microsatellite stable (MSS) advanced colorectal cancer who have failed one or more second-line standard chemotherapy regimens. It will also learn about the efficacy and safety of the combination therapy. The main questions the trial aims to answer are:

Does combination therapy reduce the overall survival time ? What medical problems do people have when they take combination therapy?

Participants will

Regorafenib, take for 2 weeks and stop for 1 week; Sintilimab, intravenous, every 3 weeks; Electroacupuncture was performed 1 day before, on the day of, and on the 2nd day after each cycle of Sintilimab administration, and patients completed 3 treatments in week 1, followed by 1 treatment per week for 2 weeks, with 5 treatments per dosing

Primary Outcome Measures: Overall survival (OS), The time from randomization to death, Up to 2 years
Secondary Outcome Measures: Objective response rate (ORR), The proportion of patients that respond either partially or fully to therapy, Up to 2 years|Progression-free survival (PFS), The time from randomization until first evidence of disease progression or death, Up to 2 years|Disease control rate (DCR), Percentage of patients with advanced cancer whose therapeutic intervention has led to a complete response, partial response, or stable disease, Up to 2 years|Time to progression (TTP), The time from randomization until first evidence of disease progression, Up to 2 years|Health-related quality of life (HRQoL), Assessment of patient quality of life with respect to health status, Up to 2 years|Adverse events (AE), Use the Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Grade refers to the severity of the AE. The CTCAE v4.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE.

Overall incidence of TEAE;

* Incidence of grade 3 or higher AE;
* Incidence of SAEs;
* Incidence of AEs leading to permanent discontinuation;
* Incidence of AEs leading to medication suspension or dose adjustment., Up to 2 years|Cancer-related fatigue(CRF), A distressing, persistent, subjective sense of physical, emotional, and/or cognitive tiredness or exhaustion related to cancer and/or cancer treatment that is not proportional to recent activity and interferes with usual functioning, use the Revised Piper Fatigue Scale (RPFS), Up to 2 years|Biomarker, Biomarker analysis can be categorized as "non-genetic" (e.g., associated proteins) or "genetically relevant" (e.g., associated RNA or DNA)., Up to 2 years|Cmax, Based on non-compartmental PK evaluation.Cmax refers to the highest measured drug concentration which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample.

Blood samples should be collected within 2 hours before electroacupuncture administration and 1 to 4 hours after electroacupuncture by weeks 2 and 3, and 2 hours before electroacupuncture in cycles 4-6, Up to 2 years|Immune-related adverse event (irAE), Up to 2 years