Camrelizumab Combined With Neoadjuvant Chemotherapy After Stent Placement for Left-Sided Obstructive Colonic Cancer
Status:
Recruiting
Trial end date:
2026-12-30
Target enrollment:
Participant gender:
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.