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Trial Title:
A Prospective Study of MSS-type Metastatic Colorectal Cancer Receiving Multiple Lines of Standard Chemotherapy, Bevacizumab Combined With Adebrelimab
NCT ID:
NCT06513221
Condition:
Metastatic Colorectal Cancer
Conditions: Official terms:
Colorectal Neoplasms
Bevacizumab
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Chemotherapy, Bevacizumab, Adebrelimab
Description:
Adebrelimab: 1200mg，q3w Bevacizumab: 7.5mg/kg，q3w Fruquintinib: 4mg po d1~d14, q3w
Chemotherapy: XELOX/mXELIRI: conventional dose
Arm group label:
First Line treatment
Arm group label:
Second Line treatment
Arm group label:
Third Line treatment
Summary:
This study is a prospective, multi-arm, phase II clinical trial that uses transcriptome
profiling to guide the evaluation of the efficacy of multiple lines of standard
chemotherapy and bevacizumab combined with adebrelimab in patients with MSS-type
metastatic colorectal cancer, aiming to expand the immunotherapy cohort while accurately
narrowing the population of MSS-type colorectal cancer that benefits from immunity. This
study includes a screening period, a treatment period, and a follow-up period.
Detailed description:
This study plans to include a total of 100 first-line, second-line, and third-line MCRIH
(MSS Colorectal Cancer Immuno-Hot) participants. First-line and second-line participants
who pass the screening period will receive standard chemotherapy (XELOX/mXELIRI:
conventional dose) combined with Bevacizumab (7.5mg/kg, q3w) and Adebrelimab (1200mg,
q3w); third-line subjects will receive Fruquintinib (4mg po d1~d14, q3w) combined with
Adebrelimab (1200mg, q3w). Participants will receive imaging examinations during the
treatment period to evaluate efficacy and progression. In addition, any adverse reactions
at any time will be recoded to evaluate safety. The EDC system will be used to collect
statistics on participants examination data.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Voluntary participation and written informed consent
2. Aged 18 years and above, regardless of gender;
3. Histologically confirmed, resectable primary lesions, unresectable metastatic
lesions, MSS-type mCRC
4. MCRIH by transcriptome typing;
5. At least one measurable lesion diagnosed by imaging, according to the solid tumor
response evaluation criteria (RECIST1.1);
6. Estimated survival ≥ 3 months;
7. ECOG score 0-1 points;
8. 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
9. Male subjects and women of childbearing age must take contraceptive measures from
the first dose to 3 months after the last dose;
10. It is expected that the patient will have good compliance and can cooperate with the
study as required by the protocol;
Exclusion Criteria:
1. Known allergy to the study drug or any of its excipients;
2. Previous treatment with immune checkpoint inhibitors;
3. 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;
4. Presence of any active autoimmune disease or history of autoimmune disease and
expected recurrence;
5. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem
cell transplantation;
6. 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;
7. 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;
8. History of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess
or active gastrointestinal bleeding within 6 months before the first study
treatment;
9. Urine protein ≥++ or 24-hour urine protein > 1.0g;
10. 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;
11. Pregnant or lactating women, and subjects with reproductive capacity who are
unwilling to take effective contraceptive measures;
12. 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;
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
July 25, 2024
Completion date:
April 12, 2027
Lead sponsor:
Agency:
Fudan University
Agency class:
Other
Source:
Fudan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06513221
