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Regorafenib and Sintilimab in Combination with Electroacupuncture in MSS CRC | Clinical Trials | Clareo Health

RECRUITINGNA

Regorafenib and Sintilimab in Combination with Electroacupuncture in MSS CRC

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

NCT06456515•The First People's Hospital of Changzhou

View on ClinicalTrials.gov

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

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Fullly knowledge of the study and voluntarily sign the informed consent;
•2. Histologically and/or cytologically confirmed metastatic colorectal adenocarcinoma (Stage IV) with microsatellite stable (MSS)\* confirmed by PCR or NGS;
•3. Receive at least two lines of standard chemotherapy in the past and have failed.
•4. 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
•5. Willing to receive electroacupuncture;
•6. Aged 18-75 years old (including 18 years old and 75 years old);
•7. Weighing more than 40 kg (including 40 kg);
•8. Able to take oral medication.
•9. 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)
•10. Eastern Cooperative Oncology Group Physical Performance Score (ECOG PS) ≤ 1 (0-1);
+3 more criteria

Exclusion Criteria

•Patients will be excluded from the study if any of the following criteria are met.
•1. Patients who have received systemic chemotherapy, radiotherapy, surgery, hormonal therapy or immunotherapy \<2 weeks prior to enrolment. Immune checkpoint blockade pretreatment is permitted.
•2. Patients with a history of regorafenib administration.
•3. Patients with uncontrolled hypertension (systolic blood pressure ≥160 mmHg and diastolic blood pressure ≥90 mmHg) despite multiple antihypertensive medications; and
•4. 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;
•5. Patients with a large pleural effusion or ascites requiring drainage; and
•6. Patients with grade ≥ 3 active infection according to NCI CTC AE version 4.03; patients with symptomatic brain metastases; and patients with a history of coronary artery angioplasty or stenting within the previous 6 months.
•7. Patients with symptomatic brain metastases;
•8. Patients with partial or complete gastrointestinal obstruction;
•9. Patients with interstitial lung disease with active signs or symptoms;
+11 more criteria

Locations (1)

The First People's Hospital of Changzhou

Changzhou, China

Key Dates

Start Date

May 1, 2024

Primary Completion Date

March 1, 2026

Completion Date

March 1, 2026

Last Updated

February 17, 2025

Enrollment

ESTIMATED participants

Conditions

Colorectal Cancer Metastatic

Interventions

Regorafenib and Sintilimab in combination with electroacupuncture

DRUG

Contacts

Wenwei Hu

CONTACT

13912330886 ei1979@163.com

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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: February 17, 2025Data 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.

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Regorafenib and Sintilimab in Combination with Electroacupuncture in MSS CRC

Inclusion Criteria

Exclusion Criteria

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