Combining Camrelizumab with chemotherapy for left-sided obstructive colorectal cancer
Camrelizumab Combined With Neoadjuvant Chemotherapy After Stent Placement Versus Surgery Alone for Left-Sided Obstructive Colonic Cancer
This study tests if combining a new immunotherapy drug with chemotherapy can help people with left-sided obstructive colorectal cancer live longer and have better surgery outcomes after getting a stent.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Beijing Chao Yang Hospital Academic / other |
| Drugs / interventions | chemotherapy, Camrelizumab, Immunotherapy |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT05202314 on ClinicalTrials.gov |
What this trial studies
This study investigates the use of Camrelizumab, an anti-PD-1 immunotherapy, in combination with neoadjuvant chemotherapy for patients with left-sided obstructive colorectal cancer who have undergone stent placement. The approach aims to improve overall survival by addressing micrometastasis and enhancing the success rate of primary anastomosis while reducing the risk of stoma formation. Patients will receive treatment after stenting, allowing for better bowel decompression before surgery. The study evaluates the effectiveness of this combined treatment in improving patient outcomes compared to traditional emergency surgery.
Who should consider this trial
Good fit: Ideal candidates are patients with radiologically confirmed left-sided colonic obstruction due to carcinoma who are eligible for surgery.
Not a fit: Patients with distal rectal cancers, signs of peritonitis, or those with unresectable colorectal cancer will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve survival rates and quality of life for patients with obstructive colorectal cancer.
How similar studies have performed: Previous studies have shown that using self-expanding metallic stents as a bridge to surgery can improve outcomes, suggesting potential success for this novel combination approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Radiologically proven colonic obstruction of the left colon/upper rectum presumed secondary to a carcinoma * Able to give written, informed consent * Primary tumor was resectable * ECOG score 0 or 1 * Haemoglobin greater than 100 g/L after transfusion before chemotherapy, * White blood cells greater than 3.0×10# /L * Platelets greater than 100×10# / L; * Glomerular filtration rate greater than 50 mL per minute as calculated by the Wright or Cockroft formula * Bilirubin less than 1.5×Upper Limit of Normal(ULN) * ALT and AST less than 2.5×ULN Exclusion Criteria: * Distal rectal cancers(equal or less than 10cm from the anal verge) * Patients with signs of peritonitis and/or bowel perforation * Patients who did not give informed consent * Patients who were considered unfit for operative treatment or refuse surgery. * Patients with suspected or proven metastatic adenocarcinoma; * Patients with unresectable colorectal cancer, or planning for palliative treatment.
Where this trial is running
Beijing, Beijing Municipality
- Beijing Chaoyang Hospital, Capital Medical University — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Principal investigator: Zhen Jun Wang, MD — Beijing Chao Yang Hospital
- Study coordinator: Jia Gang Han, MD
- Email: hjg211@163.com
- Phone: +861085231604
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.