A Prospective Study of MSS-type Metastatic Colorectal Cancer Receiving Multiple Lines of Standard Chemotherapy, Bevacizumab Combined With Adebrelimab
A Prospective, Multi-arm, Phase II Clinical Study of MSS-type Metastatic Colorectal Cancer Receiving Multiple Lines of Standard Chemotherapy, Bevacizumab Combined With Adebrelimab Under the Guidance of Transcriptome Profiling.
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Phase 2
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Voluntary participation and written informed consent
- Aged 18 years and above, regardless of gender;
- Histologically confirmed, resectable primary lesions, unresectable metastatic lesions, MSS-type mCRC
- MCRIH by transcriptome typing;
- At least one measurable lesion diagnosed by imaging, according to the solid tumor response evaluation criteria (RECIST1.1);
- Estimated survival ≥ 3 months;
- ECOG score 0-1 points;
Adequate organ and bone marrow function:
Neutrophil count: ≥1.5*10^9/L Platelet count: ≥10.0*10^9/L Hemoglobin: ≥ 9.0 g/dL Total bilirubin: ≤ 1.5 ULN AST, ALT: ≤ 2.5 *ULN (or <5*ULN in case of liver metastasis) Serum creatinine: 1.25 *ULN
- Male subjects and women of childbearing age must take contraceptive measures from the first dose to 3 months after the last dose;
- It is expected that the patient will have good compliance and can cooperate with the study as required by the protocol;
Exclusion Criteria:
- Known allergy to the study drug or any of its excipients;
- Previous treatment with immune checkpoint inhibitors;
Received the following treatments or drugs before the first study treatment:
- Major surgery within 28 days before treatment (tissue biopsy for diagnostic purposes is allowed).
- Use of immunosuppressive drugs within 7 days before treatment, excluding nasal spray and inhaled corticosteroids or physiological doses of systemic steroid hormones (i.e. no more than 10 mg/d of prednisone or other corticosteroids of equivalent physiological dose);
- Received immunomodulatory drugs (such as thymosin, interferon, interleukin) within 3 weeks before medication;
- Received live attenuated vaccines within 28 days before treatment;
- Received other anti-tumor systemic treatment within 28 days before treatment;
- Presence of any active autoimmune disease or history of autoimmune disease and expected recurrence;
- Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
- Human immunodeficiency virus (HIV) infection or known AIDS, untreated active hepatitis, HBV-DNA ≥ 2500 IU/ml and abnormal liver function; hepatitis C or co-infection with hepatitis B and hepatitis C;
- Within 6 months before entering the study, the following conditions occurred: myocardial infarction, severe/unstable angina, NYHA Patients with grade 2 or above heart failure and clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention; hypertension that is poorly controlled by drugs;
- History of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess or active gastrointestinal bleeding within 6 months before the first study treatment;
- Urine protein ≥++ or 24-hour urine protein > 1.0g;
- Unable to swallow the study drug, with multiple factors that affect drug administration and absorption, such as chronic diarrhea (including but not limited to irritable bowel syndrome, Crohn's disease, ulcerative colitis) and intestinal obstruction;
- Pregnant or lactating women, and subjects with reproductive capacity who are unwilling to take effective contraceptive measures;
- Patients with other serious physical or laboratory abnormalities that may increase the risk of participating in the study or interfere with the study results, and patients who are considered unsuitable for participation in this study by the investigator;
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: First Line treatment
Participants will recieve chemotherapy (XELOX: Oxaliplatin injection and capecitabine tablets) combined with Bevacizumab (7.5mg/kg, q3w) as well as Adebrelimab (1200mg, q3w).
|
Adebrelimab: 1200mg,q3w Bevacizumab: 7.5mg/kg,q3w Fruquintinib: 4mg po d1~d14, q3w Chemotherapy: XELOX/mXELIRI: conventional dose
|
|
Experimental: Second Line treatment
Participants will recieve chemotherapy (mXELIRI: capecitabine tablets plus irinotecan injection) combined with Bevacizumab (7.5mg/kg, q3w) as well as Adebrelimab (1200mg, q3w).
|
Adebrelimab: 1200mg,q3w Bevacizumab: 7.5mg/kg,q3w Fruquintinib: 4mg po d1~d14, q3w Chemotherapy: XELOX/mXELIRI: conventional dose
|
|
Experimental: Third Line treatment
Participants will recieve Fruquintinib (4mg po d1~d14, q3w) combined with Adebrelimab (1200mg, q3w).
|
Adebrelimab: 1200mg,q3w Bevacizumab: 7.5mg/kg,q3w Fruquintinib: 4mg po d1~d14, q3w Chemotherapy: XELOX/mXELIRI: conventional dose
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Objective Response Rate
Time Frame: 2 years
|
The percentage of people in a study or treatment group who have a partial response or complete response to the treatment within a certain period of time according to RECIST 1.1.
|
2 years
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Disease Control Rate
Time Frame: 2 years
|
The percentage of patients with advanced or metastatic cancer who have achieved complete response, partial response and stable disease to a therapeutic intervention in clinical trials of anticancer agents according to RECIST 1.1.
|
2 years
|
|
Progression Free Survival
Time Frame: 2 years
|
The length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse.
In a clinical trial, measuring the progression-free survival is one way to see how well a new treatment works according to the results of RECIST 1.1.
|
2 years
|
|
Overall Survical
Time Frame: 2 years
|
The length of time from either the date of diagnosis or the start of treatment for a disease, such as cancer, that patients diagnosed with the disease are still alive.
In a clinical trial, measuring the overall survival is one way to see how well a new treatment works.
|
2 years
|
|
QoL
Time Frame: 2 years
|
QoL will be eveluated based on EORTC QLQ-C30
|
2 years
|
|
Incidence of Treatment-related Adverse Events (Safety )
Time Frame: 2 years
|
This will be evaluated based on NCI CTCAE, including the number of participants with Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment.
|
2 years
|
Collaborators and Investigators
Sponsor
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
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
- Antineoplastic Agents
- Antineoplastic Agents, Immunological
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Bevacizumab
Other Study ID Numbers
Other Study ID Numbers
- FORESIGHT
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.