Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
NCT05202314

Camrelizumab Combined With Neoadjuvant Chemotherapy After Stent Placement for Left-Sided Obstructive Colonic Cancer

Led by Beijing Chao Yang Hospital · Updated on 2023-02-21

20

Participants Needed

1

Research Sites

263 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Camrelizumab Combined With Neoadjuvant Chemotherapy After Stent Placement for Left-Sided Obstructive Colonic Cancer

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Radiologically proven colonic obstruction of the left colon or upper rectum presumed secondary to carcinoma
  • Able to give written, informed consent
  • Primary tumor is resectable
  • ECOG performance score 0 or 1
  • Hemoglobin greater than 100 g/L after transfusion before chemotherapy
  • White blood cell count greater than 3.0 x 10^9 /L
  • Platelet count greater than 100 x 10^9 /L
  • Glomerular filtration rate greater than 50 mL per minute
  • Bilirubin less than 1.5 times the upper limit of normal
  • ALT and AST less than 2.5 times the upper limit of normal
Not Eligible

You will not qualify if you...

  • Distal rectal cancers located 10 cm or less from the anal verge
  • Signs of peritonitis and/or bowel perforation
  • Patients who did not give informed consent
  • Patients unfit for surgery or who refuse surgery
  • Suspected or confirmed metastatic adenocarcinoma
  • Unresectable colorectal cancer or planned palliative treatment

AI-Screening

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Trial Site Locations

Total: 1 location

1

Beijing Chaoyang Hospital, Capital Medical University

Beijing, Beijing Municipality, China, 100020

Actively Recruiting

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Research Team

J

Jia Gang Han, MD

CONTACT

Z

Zhi Wei Zhai, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Camrelizumab Combined With Neoadjuvant Chemotherapy After Stent Placement for Left-Sided Obstructive Colonic Cancer | DecenTrialz