New treatment approach for advanced colorectal cancer using chemotherapy and immunotherapy

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

This study is testing a new treatment that combines chemotherapy and immunotherapy to see if it can help people with advanced colorectal cancer that can't be surgically removed.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Jinhua Central Hospital (Academic / other)
• Drugs / interventions: Fruquintinib, chemotherapy, radiation, bevacizumab, immunotherapy
• Locations: 1 site (Jinhua, Zhejiang)
• Trial ID: NCT06176885 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the efficacy and safety of a novel treatment combining chemotherapy and bevacizumab induction therapy with immunotherapy for patients with initially unresectable metastatic colorectal cancer. The study focuses on patients with microsatellite stable (MSS) tumors and seeks to determine the treatment's effectiveness and safety profile. Participants will receive the immunotherapy agent Camrelizumab following the initial chemotherapy and bevacizumab treatment. The trial will also assess the characteristics of the patient population that may benefit from this combined approach.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18-75 with unresectable metastatic colorectal cancer who have not previously received treatment.

Not a fit: Patients with resectable metastatic colorectal cancer or those with significant comorbidities that may affect treatment outcomes may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new first-line option for patients with advanced colorectal cancer, potentially improving survival rates and quality of life.

How similar studies have performed: Other studies have shown promising results with similar combinations of chemotherapy and immunotherapy in treating colorectal cancer, indicating potential for success.

Eligibility criteria

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

Where this trial is running

Jinhua, Zhejiang

• Department of Colorectal Surgery, Affiliated Jinhua Hosptial, Zhejiang University — Jinhua, Zhejiang, China (Recruiting)

Conditions Colorectal Cancer; colorectal cancer; Hepatopulmonary metastasis; Camrelizumab; MSS; Bevacizumab