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RecruitingNCT06176885FOBECAMSUpdated Dec 27, 2023

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

A Phase 2 interventional study of Camrelizumab in Colorectal Cancer, sponsored by yue junhan. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-12-27.

Sponsored by yue junhan · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2025, 10 months ago, but the record still lists the study as recruiting.
Phase
Phase 2
Study type
Interventional
Enrollment
36
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study 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.
02

Conditions studied

  • Colorectal Cancer

Keywords

  • colorectal cancer
  • Hepatopulmonary metastasis
  • Camrelizumab
  • MSS
  • Bevacizumab
03

In context

Colorectal Neoplasms

5,734 studies on the registry are indexed under Colorectal Neoplasms; 1,481 are open to participants now.

This study's planned enrollment of 36 is below the median of 77 across 4,222 interventional studies indexed under Colorectal Neoplasms.

Browse Colorectal Neoplasms studies →

Lead sponsor

This is the only study on the registry with yue junhan as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
36 participants (estimated)

Study arms

  • Experimental
    Camrelizumab Group

    Combined with Camrelizumab after irinotecan leucovorin and fluorouracil (FOLFIRI) chemotherapy and bevacizumab targeted induction therapy

    Drug: Camrelizumab

Interventions

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

06

What researchers measure

Primary outcomes

  1. PFS(Disease-free Survival)

    Disease-free Survival

    Time frame: 11.5 months

Secondary outcomes

  1. ORR(Objective Remission Rate)

    Objective Remission Rate

    Time frame: 2 years

  2. Conversion resection rate

    Conversion resection rate

    Time frame: 2 years

  3. OS(Overall Survival)

    Overall Survival

    Time frame: more than 2 years

  4. Incidence of Treatment-Emergent Adverse Events

    Treatment-Emergent Adverse Events,such as bleeding,thrombocytopenia,abnormal liver function,proteinuria,hypertension and so on

    Time frame: 2 years

  5. DCR(Disease control rate)

    Disease control rate

    Time frame: 2 years

07

Study locations

1 of 1 sites recruiting
  • Department of Colorectal Surgery, Affiliated Jinhua Hosptial, Zhejiang University
    Jinhua, Zhejiang 321000, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 27, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06176885
Lead sponsor
yue junhan
Responsible party
yue junhan (Director, Jinhua Central Hospital) — Sponsor-investigator
First posted
Dec 20, 2023
Start date
Dec 20, 2023 (estimated)
Primary completion
Dec 20, 2025 (estimated)
Completion
Dec 20, 2026 (estimated)
Last update
Dec 27, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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