Neoadjuvant Tisleizumab(BGB-A317) for dMMR/MSI-H Non-late Stage Colorectal Cancer Patients

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

According to the cancer statistics in 2020, colorectal cancer (CRC) remains a major public health issue worldwide, representing the third common cancer (10%) and second leading cause of death (9.4%) with 5-year survival rate approaching 65%. Meanwhile, 28.8% of the newly diagnosed cases and 30.3% of the CRC-related death occurs in China. Among all the CRC, stage I-III account for 75%. For the standard management for non-late stage(stage I-III) CRC patients, surgery including the primary site and local lymph nodes dissection has been the most important one. But for the high-risk stage II and locally-advanced stage III CRC, neoadjuvant or adjuvant therapy such as chemotherapy and radiotherapy plays a vital role in preventing the residual cancer cells to relapse and spread to distant sites after surgery. For the past decades, immunotherapy like anti-PD-1 and anti-CTLA4 checkpoint inhibitor achieves great process in solid tumor treatment especially for late-stage CRC. And Pembrolizumab and Nivolumab has been proved for dMMR/MSI-H late-stage-CRC by FDA. Combination of Ipilimumab and Nivolumab has achieved great success among the early-stage-CRC in NICHE study. The investigators here to carry out a phase II clinical trial to explore the safety and effect of single anti-PD-1 (Tisleizumab-BGB-A317 ) neoadjuvant treatment for non-late stage CRC patients.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Able to provide consents and agree to follow the trial requirement and assessment;

• Age \>=18

• ECOG score: 0 or1

• Biopsy pathological diagnosis as MSI-H/dMMR( both IHC and PCR method required)

• Measurable and assessible primary tumor sites according to RECIST 1.1

• Able to provide 22ml peripheral blood for assessment for ctDNA

• With all organ function sufficient

• No bowel obstruction or fistula

• No previous chemotherapy, radiotherapy and immunotherapy accepted history

• Distant metastasis excluded before surgery by CT scan

• Contraception required for women for the whole enrollment time until 3 months after last dose of immunotherapy

Locations
Other Locations
China
Sun Yat-Sen University Cancer Center
RECRUITING
Guangzhou
Contact Information
Primary
Gong Chen, Prof
chengong@sysucc.org.cn
+86 020 87343584
Backup
Rong-xin Zhang, Prof
zhangrx@sysucc.org.cn
+86 020 87343584
Time Frame
Start Date: 2023-09-23
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 40
Treatments
Experimental: dMMR/MSI-H stage I-III CRC patients
Patients will accept 4 dose of Tisleizumab(BGB-A317) treatment after enrollment and the assessment of the therapeutic effect by clinicians would be finished after that. Once the patients has been qualified as cCR , they could be exempted for surgery and continued the watch and wait management. If the patient has been assessed as able to R0 surgery , then they would received surgery. Otherwise ,they would be excluded from the trial.
Related Therapeutic Areas
Sponsors
Leads: Sun Yat-sen University

This content was sourced from clinicaltrials.gov