NCT05202314 Camrelizumab Combined With Neoadjuvant Chemotherapy After Stent Placement for Left-Sided Obstructive Colonic Cancer
| NCT ID | NCT05202314 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Beijing Chao Yang Hospital |
| Condition | Colorectal Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2021-12-12 |
| Primary Completion | 2023-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2021-12-12 with a primary completion date of 2023-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Patients with obstruction are associated with worse oncologic outcomes compared with those having nonobstructive tumors. Conventionally, patients with malignant large bowel obstruction receive emergency surgery, with morbidity rates of 30%-60% and mortality rates of 7-22%, and about two-thirds of such patients end up with a permanent stoma. Self-expanding metallic stents (SEMS) haven been used as a bridge to surgery (to relieve obstruction prior to elective surgery) in patients with potentially resectable colorectal cancer. Several clinical trials demonstrate that SEMS as a bridge to surgery may be superior to emergency surgery considering the short-term outcomes. SEMS is associated with lower morbidity and mortality rate, increased primary anastomosis rate, and decreased stoma creation rate. Although about half of patients can achieve primary anastomosis after stent placement, the primary anastomosis rate is still significantly lower compared with nonobstructing elective surgery. The interval between stent placement and surgery may be not long enough that bowel decompression is insufficient at the time of operation. Furthermore#the long-term oncologic results regarding SEMS as a bridge to surgery are still limited and contradictory. Sabbagh et al. suggest worse overall survival of patients with SEMS insertion compared with emergency surgery, the 5-year cancer-specific mortality was significantly higher in the SEMS group (48% vs 21%, respectively, P=0.02). One interpretation is that tumor cells may disseminate during the procedure of colonic stenting placement. Immunotherapy has proven to be highly effective as first-line treatment of metastatic colorectal cancer (CRC). And immunotherapy also has emerged as a neoadjuvant approach, possibly changing treatment strategy for both primary resectable and metastatic CRC. We hypothesis that, regardless of the MSI state, immunotherapy (Camrelizumab, an anti-PD-1 antibody) combined with chemotherapy after stenting may improve overall survival by eradicating micrometastasis. Moreover, immunotherapy (Camrelizumab, an anti-PD-1 antibody) combined with neoadjuvant chemotherapy prolongs the interval between stent placement and surgery, and the time for bowel decompression is more sufficient, which may increase the success rate of primary anastomosis and decrease risk of stoma formation, and furthermore, improve OS and PFS.
Eligibility 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.
Contact & Investigator
Zhen Jun Wang, MD
PRINCIPAL INVESTIGATOR
Beijing Chao Yang Hospital
Frequently Asked Questions
Who can join the NCT05202314 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Colorectal Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05202314 currently recruiting?
Yes, NCT05202314 is actively recruiting participants. Contact the research team at hjg211@163.com for enrollment information.
Where is the NCT05202314 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT05202314 clinical trial?
NCT05202314 is sponsored by Beijing Chao Yang Hospital. The principal investigator is Zhen Jun Wang, MD at Beijing Chao Yang Hospital. The trial plans to enroll 20 participants.
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