Actively Recruiting
Regorafenib and Sintilimab in Combination with Electroacupuncture in MSS CRC
Led by The First People's Hospital of Changzhou · Updated on 2025-02-17
30
Participants Needed
1
Research Sites
95 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Regorafenib and Sintilimab in Combination with Electroacupuncture in MSS CRC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Fully understand the study and voluntarily sign informed consent
- Histologically or cytologically confirmed metastatic colorectal adenocarcinoma (Stage IV) with microsatellite stable (MSS) status confirmed by PCR or NGS
- Have received at least two lines of standard chemotherapy and failed
- No systemic chemotherapy, radiotherapy, immunotherapy, biological or hormonal therapy in the past 4 weeks; no prior VEGFR inhibitors
- Willing to receive electroacupuncture
- Aged 18 to 75 years old (inclusive)
- Weigh more than 40 kg (inclusive)
- Able to take oral medication
- Adequate organ function with specified blood counts and liver, kidney, and coagulation parameters
- Eastern Cooperative Oncology Group Physical Performance Score (ECOG PS) of 0 or 1
- Cardiac function with left ventricular ejection fraction ≥ 50%
- Measurable lesions meeting RECIST 1.1 criteria
- Expected survival longer than 12 weeks
You will not qualify if you...
- Received systemic chemotherapy, radiotherapy, surgery, hormonal therapy, or immunotherapy less than 2 weeks before enrollment (immune checkpoint blockade pretreatment allowed)
- Prior treatment with regorafenib
- Uncontrolled hypertension despite multiple medications (systolic ≥160 mmHg or diastolic ≥90 mmHg)
- Acute coronary syndromes or coronary angioplasty/stenting within 6 months
- Large pleural effusion or ascites requiring drainage
- Grade 3 or higher active infection
- Symptomatic brain metastases
- Partial or complete gastrointestinal obstruction
- Active interstitial lung disease
- Positive for HIV-1, HIV-2, hepatitis B surface antigen, or hepatitis C virus; or active hepatitis B infection
- Concurrent or history of chronic/recurrent autoimmune disease
- Require systemic corticosteroids or immunosuppressive agents within 14 days before study
- History of class III or higher congestive heart failure
- Epilepsy requiring medication
- Grade 3 or higher bleeding within 4 weeks before enrollment
- Major surgery or trauma within 28 days before enrollment
- Non-healing wounds, ulcers, or fractures
- History of hypersensitivity to investigational drugs or components
- Women who are pregnant, breastfeeding, or may become pregnant
- Contraindications to electroacupuncture or as per traditional Chinese medicine syndromes
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Trial Site Locations
Total: 1 location
1
The First People's Hospital of Changzhou
Changzhou, China
Actively Recruiting
Research Team
W
Wenwei Hu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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