A Single-Arm, Multicenter Phase II Clinical Study of Regorafenib and Sintilimab in Combination with Electroacupuncture in Patients with MSS Advanced Colorectal Cancer Who Have Failed More Than Second-Line Standard Chemotherapy
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
• Willing to receive electroacupuncture;
• Aged 18-75 years old (including 18 years old and 75 years old);
• Weighing more than 40 kg (including 40 kg);
• Able to take oral medication.
• Patients with adequate organ function at the time of enrollment are defined as follows: Neutrophil count ≥1500mm3 Platelet count ≥10.0 × 104/mm3 Hemoglobin (Hb) ≥ 9 g/dL Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤100 U/L (≤100 U/L in patients with hepatocellular carcinoma, ≤250 U/L in patients with liver metastasis) Total bilirubin ≤1.5 mg /dL Creatinine ≤1.5 mg /dL Lipase ≤ 80 IU/L Urine Protein: one of the following (if any of the criteria are met, no other test may be performed) (i) Urine Protein (paper test) of 2+ or less (ii) UPC \< 3.5 (iii) Urine Protein ≦ 3500 mg for 24 hour urine protein measurements. mg Prothrombin time (PT)-International Normalized Ratio (INR): ≤ 1.5 (≤ 3.0 for anticoagulant administration)
⁃ Eastern Cooperative Oncology Group Physical Performance Score (ECOG PS) ≤ 1 (0-1);
⁃ Cardiac function evaluation: left ventricular ejection fraction ≥ 50% (echocardiography);
⁃ Clearly meet the criteria for evaluating the efficacy of solid tumors (e.g., echocardiograms) Measurable lesions that meet the requirements of RECIST 1.1;
⁃ Expected survival of more than 12 weeks.