A Prospective Study of MSS-type Metastatic Colorectal Cancer Receiving Multiple Lines of Standard Chemotherapy, Bevacizumab Combined With Adebrelimab

NCT06513221 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: FORESIGHT
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Metastatic Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate

  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 Outcomes (5)

• Disease Control Rate

  2 years

• Progression Free Survival

  2 years

• Overall Survical

  2 years

• QoL

  2 years

• Incidence of Treatment-related Adverse Events (Safety )

  2 years

Study Arms (3)

First Line treatment

EXPERIMENTAL

Participants will recieve chemotherapy (XELOX: Oxaliplatin injection and capecitabine tablets) combined with Bevacizumab (7.5mg/kg, q3w) as well as Adebrelimab (1200mg, q3w).

Drug: Chemotherapy, Bevacizumab, Adebrelimab

Second Line treatment

EXPERIMENTAL

Participants will recieve chemotherapy (mXELIRI: capecitabine tablets plus irinotecan injection) combined with Bevacizumab (7.5mg/kg, q3w) as well as Adebrelimab (1200mg, q3w).

Drug: Chemotherapy, Bevacizumab, Adebrelimab

Third Line treatment

EXPERIMENTAL

Participants will recieve Fruquintinib (4mg po d1\~d14, q3w) combined with Adebrelimab (1200mg, q3w).

Drug: Chemotherapy, Bevacizumab, Adebrelimab

Interventions

Chemotherapy, Bevacizumab, Adebrelimab DRUG

Adebrelimab: 1200mg，q3w Bevacizumab: 7.5mg/kg，q3w Fruquintinib: 4mg po d1\~d14, q3w Chemotherapy: XELOX/mXELIRI: conventional dose

First Line treatment; Second Line treatment; Third Line treatment

Eligibility Criteria

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

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Fudan University: lead

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Drug Therapy; Bevacizumab

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)

Therapeutics; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Chief of Department of Colorectal Surgery

Study Record Dates

• First Submitted: July 3, 2024
• First Posted: July 22, 2024
• Study Start: July 25, 2024
• Primary Completion: April 1, 2026
• Study Completion (Estimated): April 12, 2027
• Last Updated: July 22, 2024

Record last verified: 2024-07