BridgeMD
New treatment option for Colorectal Cancer Metastatic
Official title Regorafenib and Sintilimab in Combination with Electroacupuncture in MSS CRC
ClinicalTrials.gov ID: NCT06456515
What this study is testing
What is Regorafenib and Sintilimab in combination with electroacupuncture?
Regorafenib and Sintilimab in combination with electroacupuncture is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for colorectal cancer metastatic.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join 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...
- 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...
- Willing to receive electroacupuncture;
You likely can't join 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...
- 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...
- Patients with acute coronary syndromes (including myocardial infarction and unstable angina) and a history of coronary angioplasty or stenting within...
- Patients with a large pleural effusion or ascites requiring drainage; and
See the full eligibility criteria
- 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...
- 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 how well it works of solid tumors (e.g., echocardiograms) Measurable lesions that meet the requirements of RECIST 1.1;
- Expected survival of more than 12 weeks.
- 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...
- 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...
- 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...
- 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;
- Patients with grade 3 or greater bleeding within 4 weeks prior to enrolment.
- Patients who have undergone major surgery (open heart or caesarean section, etc.), caesarean biopsy, or trauma within 28 days prior to enrolment. the same day of the week prior to the 4-week period may be enrolled...
- Patients with non-healing wounds, non-healing ulcers or non-healing fractures.
- Patients with a history of hypersensitivity reaction to any investigational drug, analogue or excipient.
- Women who are pregnant or breastfeeding or have the potential to become pregnant.
- Patients with contraindications to electroacupuncture therapy or patients for whom electroacupuncture is contraindicated in accordance with TCM syndromes.
The study team makes the final eligibility decision.
Where it's taking place
- Changzhou, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Changzhou, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.