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
Fullly knowledge of the study and voluntarily sign the informed consent;
Histologically and/or cytologically confirmed metastatic colorectal adenocarcinoma (Stage IV) with microsatellite stable (MSS)* confirmed by PCR or NGS;
Receive at least two lines of standard chemotherapy in the past and have failed.
No systemic chemotherapy or antitumor therapy such as radiotherapy, immunotherapy, biological or hormonal therapy in the past 4 weeks; and have never received VEGFR inhibitors
Patients who have received systemic chemotherapy, radiotherapy, surgery, hormonal therapy or immunotherapy <2 weeks prior to enrolment. Immune checkpoint blockade pretreatment is permitted.
Patients with a history of regorafenib administration.
Patients with uncontrolled hypertension (systolic blood pressure ≥160 mmHg and diastolic blood pressure ≥90 mmHg) despite multiple antihypertensive medications; and
Patients with acute coronary syndromes (including myocardial infarction and unstable angina) and a history of coronary angioplasty or stenting within 6 months prior to enrolment;
Single group
Regorafenib and Sintilimab in combination with electroacupuncture
DrugRegorafenib, 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 cycle.
Overall survival (OS)
The time from randomization to death
Objective response rate (ORR)
The proportion of patients that respond either partially or fully to therapy
Progression-free survival (PFS)
The time from randomization until first evidence of disease progression or death
Disease control rate (DCR)
Percentage of patients with advanced cancer whose therapeutic intervention has led to a complete response, partial response, or stable disease
Time to progression (TTP)
The time from randomization until first evidence of disease progression
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