Efficacy and Safety of Combined With Immunotherapy After Induction Therapy With Chemotherapy and Targeted Therapy in the First-line Treatment of Microsatellite Stable (MSS) Initially Unresectable Metastatic Colorectal Cancer

Colorectal Cancer Clinical Trial

— FOBECAMS  

Official title:

Efficacy and Safety of Camrelizumab Combined With Irinotecan, Leucovorin and Fluorouracil (FOLFIRI) Chemotherapy and Bevacizumab Targeted Induction Therapy in the First-line Treatment of Microsatellite Stable (MSS) Initially Unresectable Metastatic Colorectal Cancer: a Prospective, Multicenter, Single-arm Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06176885
• Other study ID #: 321000
• Status: Recruiting
• Phase: Phase 2
• Start date: December 20, 2023
• Est. completion date: December 20, 2026

Study information

• Verified date: December 2023
• Source: Jinhua Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this clinical trial is to explore the feasibility of a new mode of chemotherapy and bevacizumab induction therapy combined with immunotherapy as first-line treatment for patients with initially unresectable metastatic colorectal cancer (MSS). The main questions it aims to answer are:

1. To explore the efficacy and safety of this treatment mode

2. Try to study treatment benefit the characteristics of the crowd Participants will combined with immunotherapy after chemotherapy and bevacizumab induction therapy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: December 20, 2026
• Est. primary completion date: December 20, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Patients voluntarily participated in the study signed the informed consent and had good compliance

2. Body weight =40kg

3. Metastatic colorectal cancer confirmed by histology and/or cytology and initially unresectable

4. Microsatellite instable (MSS) or proficient Mismatch Repair (pMMR)

5. Patients have at least one measurable lesion (RECIST 1.1)

6. Eastern Cooperative Oncology Group Physical Status (ECOG PS) 0-1

7. Expected survival =12 weeks

8. Blood testing (not corrected with granulocyte colony-stimulating factor or other hematopoietic stimulating factor within 7 days prior to laboratory testing if not transfused within 14 days)

9. Women of reproductive age had to have a serum pregnancy test with a negative result within 14 days before treatment and be willing to use a medically approved effective contraceptive during the study and for 3 months after the last dose of study medication

10. Age 18-75 years old (including 18 and 75 years old)

Exclusion Criteria:

1. The patient had received radiation therapy surgery chemotherapy immune or molecular-targeted therapy or other investigational drugs within 4 weeks before treatment

2. An active autoimmune disease requiring systemic therapy (i.e., disease-modifying medications, corticosteroids, or immunosuppressive agents) had occurred within the previous 2 years. Replacement therapies, such as thyroxine, insulin, or physiological corticosteroid replacement for adrenal or pituitary insufficiency, are not considered systemic treatments

3. Immunodeficiency was diagnosed within 7 days before the first treatment or received systemic steroid therapy or any other form of immunosuppressive therapy. Physiological doses of corticosteroids could be approved after consultation with the sponsor

4. She had previously received anti-vascular small molecule targeted drug therapy, such as Fruquintinib

5. Prior treatment with an irinotecan-based chemotherapy regimen

6. Symptomatic brain or meningeal metastases

7. Left colon cancer with wild-type rat sarcoma virus gene (RAS)

8. MSI-H or dificient Mismatch Repair (dMMR) metastatic colorectal cancer

9. Serious infection (e.g., intravenous antibiotic, antifungal, or antiviral) within 4 weeks before treatment, or unexplained fever > 38.5 ° C during screening/first dose

10. Hypertension that is not well controlled with antihypertensive medication (systolic blood pressure =140 mmHg or diastolic blood pressure =90 mmHg)

11. The patient had obvious clinical bleeding symptoms or obvious bleeding tendency within 3 months before treatment (bleeding > 30 mL within 3 months, hematemesis, melena, hematochezia), hemoptysis (fresh blood > 5 mL within 4 weeks), etc. Or treatment for a venous/venous thrombotic event within the previous 6 months, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism Long-term anticoagulation with warfarin or heparin or long-term antiplatelet therapy (aspirin =300 mg/day or clopidogrel =75 mg/day) may be required

12. At the time of screening, tumors were found to invade large vascular structures, such as pulmonary artery, superior vena cava or inferior vena cava, which were judged by the investigator to have a high risk of bleeding

13. "Active heart disease, including myocardial infarction, severe/unstable angina, occurred 6 months before treatment." Echocardiography showed that the left ventricular ejection fraction was less than 50% and the arrhythmia was not well controlled

14. Patients with other malignant tumors (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix) within the past 5 years or at the same time

15. Known allergy to the study drug or any of its excipients

16. Severe, active or uncontrolled infection

17. Any other medical condition, clinically significant metabolic abnormality, physical examination abnormality, or laboratory abnormality, a disease or condition for which there is reason to suspect that the patient is not suitable for use of the study drug (e.g., having seizures requiring treatment), or a condition that would affect interpretation of the study results, or that would place the patient at high risk, in the investigator's judgment

18. If urine routine test showed urinary protein =2+ and 24-hour urinary protein quantitation >1.0g

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Drug:
• Camrelizumab
Combination therapy with Camrelizumab monoclonal antibody will be administered after the initial two cycles of induction therapy.

Locations

Country	Name	City	State
China	Department of Colorectal Surgery, Affiliated Jinhua Hosptial, Zhejiang University	Jinhua	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
yue junhan

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PFS(Disease-free Survival)	Disease-free Survival	11.5 months
Secondary	ORR(Objective Remission Rate)	Objective Remission Rate	2 years
Secondary	Conversion resection rate	Conversion resection rate	2 years
Secondary	OS(Overall Survival)	Overall Survival	more than 2 years
Secondary	Incidence of Treatment-Emergent Adverse Events	Treatment-Emergent Adverse Events,such as bleeding,thrombocytopenia,abnormal liver function,proteinuria,hypertension and so on	2 years
Secondary	DCR(Disease control rate)	Disease control rate	2 years