- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06206096
PD-1 Antibody Plus Bevacizumab and CAPOX as First-line Treatment for RAS-mut MSS mCRC
April 29, 2024 updated by: Dai, Guanghai, Chinese PLA General Hospital
PD-1 Antibody Plus Bevacizumab and CAPOX as First-line Treatment for Patients With RAS-mutant, Microsatellite Stable, Metastatic Colorectal Cancer: a Prospective, Open-label, Single-arm, Phase II Trial
This study is designed to explore the efficacy and safety of anti-PD-1 antibody plus bevacizumab and chemotherapy as first-line treatment for patients with RAS-mutant, microsatellite stable, metastatic colorectal cancer.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
40
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ru Jia, MD
- Phone Number: +8613811721720
- Email: ashleyjr@163.com
Study Locations
-
-
-
Beijing, China, 100853
- Recruiting
- Chinese PLA General Hospital
-
Contact:
- Guanghai Dai, PhD
- Phone Number: 13801232381
- Email: daigh301@vip.sina.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Histologically or cytologically confirmed non resectable, locally advanced or metastatic colorectal cancer;
- No previous anti-tumor treatment for metastatic diseases;
- KRAS/NRAS mutation;
- Eastern Cooperation Oncology Group (ECOG) performance status of 0-1;
- Life expectancy ≥ 3 months;
- Adequate organ and bone marrow functions:
Absolute neutrophil count≥1.5x10^9/L; Platelet count≥100x10^9/L; Hemoglobin≥9g/dL; Serum bilirubin<1.5x the upper limit of normal(ULN); Alanine aminotransferase(ALT) and aspartate aminotransferase(AST)<1.5x ULN; Serum creatinine<1.5x ULN; Endogenous creatinine clearance rate ≥ 50ml / min;
- Women of childbearing age need to take effective contraceptive measures.
Exclusion Criteria:
- Previous treatment with vascular endothelial growth factor receptor (VEGFR) inhibitors or previous use of immune checkpoint inhibitors;
- With BRAF mutation or MSI-H status;
- Other untreated or concurrent tumors (except cervical carcinoma in situ, treated basal cell carcinoma or superficial bladder tumor, or if the tumor is cured and there is no evidence of disease for more than 3 years);
- Have received other systemic anti-tumor treatments, including chemotherapy, signal transduction inhibitors, hormone therapy and immunotherapy within 4 weeks before enrollment;
- There was central nervous system (CNS) metastasis or previous brain metastasis before enrollment;
- Have received any surgery or invasive treatment or operation within 4 weeks before enrollment;
- Have received Local anti-tumor therapy such as hepatic artery interventional embolization, liver metastasis cryoablation or radiofrequency ablation within 4 weeks before enrollment;
- Uncontrolled malignant ascites;
- Participated in other clinical trials within 4 weeks before enrollment, and received corresponding experimental drug treatment;
- Allergic to the study drug or any of its adjuvants;
- International normalized ratio (INR) > 1.5 or partially activated prothrombin time (APTT) > 1.5 × ULN;
- The researchers judged clinically significant electrolyte abnormalities;
- Hypertension that cannot be controlled by drugs, which is specified as: systolic blood pressure ≥ 140 mmHg and / or diastolic blood pressure ≥ 90 mmHg; Patients currently have poorly controlled diabetes (fasting glucose level is greater than CTCAE grade 2 after regular treatment);
- Patients with dysphagia, active peptic ulcer, intestinal obstruction, active gastrointestinal bleeding, peptic perforation, malabsorption syndrome or uncontrolled intestinal inflammatory diseases;
- Any disease or state affecting drug absorption before enrollment, or the patient cannot take oral medication;
- Patients with obvious evidence of bleeding tendency or medical history within 3 months before enrollment, hemoptysis or thromboembolism within 12 months;
- Cardiovascular diseases with significant clinical significance, including but not limited to acute myocardial infarction, severe / unstable angina pectoris or coronary artery bypass grafting within 6 months before enrollment; Congestive heart failure, New York Heart Association (NYHA) grade > 2; ventricular arrhythmia requiring drug treatment; LVEF (left ventricular ejection fraction) < 50%;
- Active infection or serious infection that is not controlled by drug (≥CTCAE v5.0 Grade 2);
- History of clinically significant hepatic disease, including, but not limited to, known hepatitis B virus (HBV) infection with HBV DNA positive (copies ≥1×10^4/ml or >2000 IU/ml); known hepatitis C virus infection with HCV RNA positive (copies ≥1×10^3/m); hepatitis and cirrhosis;
- Women who are pregnant or lactating;
- Urinary protein ≥ ++, and the 24-hour urine protein quantification is greater than 1.0g;
- Have any other disease, metabolic disorder, physical examination anomaly, abnormal laboratory result, or any other conditions that makes the subject not suitable for enrolling according to the judgment of the investigator.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: CAPOX+BEV+PD-1
|
oxaliplatin will be administered once every 3 weeks at a dose of 130 mg/m2; Capecitabine will be taken orally at a dose of 1g/m2 twice daily for continuous oral administration over 14 days; Bevacizumab will be administered intravenously every 3 weeks at a dose of 7.5 mg/kg; PD-1 antibody was given due to different types.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ORR
Time Frame: up to 3 years
|
The proportion of patients with a confirmed complete response or partial response
|
up to 3 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PFS
Time Frame: up to 3 years
|
The time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first
|
up to 3 years
|
DCR
Time Frame: up to 3 years
|
The proportion of patients with a best overall response of confirmed complete or partial response, or stable disease (CR+ PR + SD)
|
up to 3 years
|
OS
Time Frame: up to 3 years
|
The time from randomization to death from any reason
|
up to 3 years
|
Safety and tolerability by incidence, severity and outcome of adverse events
Time Frame: up to 3 years
|
Safety and tolerance will be evaluated by incidence, severity and outcomes of adverse events (AEs) and categorized by severity in accordance with the NCI CTC AE Version 5.0
|
up to 3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Guanghai Dai, MD, Chinese PLA General Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 26, 2021
Primary Completion (Estimated)
December 1, 2024
Study Completion (Estimated)
December 1, 2025
Study Registration Dates
First Submitted
January 4, 2024
First Submitted That Met QC Criteria
January 4, 2024
First Posted (Actual)
January 16, 2024
Study Record Updates
Last Update Posted (Estimated)
April 30, 2024
Last Update Submitted That Met QC Criteria
April 29, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Colonic Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Colorectal Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunologic Factors
- Antineoplastic Agents, Immunological
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Antibodies
- Capecitabine
- Oxaliplatin
- Bevacizumab
Other Study ID Numbers
- ZLNK-CRC-01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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