Regorafenib and Sintilimab in Combination with Electroacupuncture in MSS CRC

NCT06456515 | Recruiting

• 1 other identifier: F-IRB-SOP-00710
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Colorectal Cancer Metastatic

Keywords

Regorafenib; Sintilimab; electroacupuncture; colorectal cancer

Outcome Measures

Primary Outcomes (1)

• Overall survival (OS)

  The time from randomization to death

  Up to 2 years

Secondary Outcomes (10)

• Objective response rate (ORR)

  Up to 2 years

• Progression-free survival (PFS)

  Up to 2 years

• Disease control rate (DCR)

  Up to 2 years

• Time to progression (TTP)

  Up to 2 years

• Health-related quality of life (HRQoL)

  Up to 2 years

Study Arms (1)

Regorafenib and Sintilimab in combination with electroacupuncture

EXPERIMENTAL

Drug: Regorafenib and Sintilimab in combination with electroacupuncture

Interventions

Regorafenib and Sintilimab in combination with electroacupuncture DRUG

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 cycle.

Regorafenib and Sintilimab in combination with electroacupuncture

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients will be excluded from the study if any of the following criteria are met.
• 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;
• Patients with a large pleural effusion or ascites requiring drainage; and
• 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.
• Patients with symptomatic brain metastases;
• Patients with partial or complete gastrointestinal obstruction;
• Patients with interstitial lung disease with active signs or symptoms;
• Patients who test positive for anti-HIV-1 antibody, anti-HIV-2 antibody, hepatitis B surface antigen (HBsAg), or anti-hepatitis C virus (HCV)\* \*Patients who test positive for anti-hepatitis B surface (HBs) or anti-hepatitis B core (HBc) antibodies and patients with hepatitis B virus (HBV)-DNA measurements that are greater than the sensitivity of the test will also be excluded. Patients with concurrent autoimmune disease
• Patients with concurrent autoimmune disease or a history of chronic or recurrent autoimmune disease.
• Patients requiring systemic corticosteroids (excluding those given temporarily for testing, prophylactic administration for allergic reactions, or for the relief of swelling associated with radiotherapy) or immunosuppressive agents, or who have received such therapy \<14 days prior to study participation;
• Patients with a history or finding of class ≥III congestive heart failure according to the New York Heart Association functional class;
• Patients with epilepsy requiring pharmacological treatment;

Sponsors & Collaborators

• The First People's Hospital of Changzhou: lead

Study Sites (1)

The First People's Hospital of Changzhou

Changzhou, China

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

regorafenib; sintilimab; Electroacupuncture

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Acupuncture Therapy; Complementary Therapies; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Transcutaneous Electric Nerve Stimulation; Analgesia; Anesthesia and Analgesia; Anesthesia

Central Study Contacts

Wenwei Hu

CONTACT

13912330886; ei1979@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Director of Oncology Department

Study Record Dates

• First Submitted: May 21, 2024
• First Posted: June 13, 2024
• Study Start: May 1, 2024
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: February 17, 2025

Record last verified: 2025-02

Locations

CN (1)