Neoadjuvant Tisleizumab(BGB-A317) for dMMR/MSI-H Non-late Stage CRC Patients Before Surgery

Last updated: February 15, 2024
Sponsor: Sun Yat-sen University
Overall Status: Active - Recruiting

Phase

2

Condition

Cancer

Chemotherapy

Vaccines

Treatment

Tisleizumab(BGB-A317)

Clinical Study ID

NCT06262581
2021-FXY-471
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • 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 afterlast dose of immunotherapy

Exclusion

Exclusion Criteria:

  • self-autoimmune diseases history such as SLE
  • People who using the immune suppressor
  • Severe allergy to other mono-clone antibody
  • Cerebral metastasis which hasn't be managed yet
  • Hypertension(SBP>140mmHg，DBP>90mmHg)
  • Uncontrolled diabetes(FBG>10mmol/L)
  • Accepted anti-PD-1 or anti-PD-L1 immunotherapy in the past
  • Uncontrolled heart diseases such as NYHA II heart failure, unstable angina , cardiacinfarction in 1 year and arrhythmia
  • Systemic inflammation which needs whole body treatment
  • Urine routine: protein >=++ or 24hr urine protein>=1g
  • Innate or acquired immune deficiency like HIV and HBV
  • Enrolled in other clinical trial already
  • Confirmed as metastasis before the surgery
  • Other malignancies has been diagnosed before
  • Tuberculosis
  • Pregnancy

Study Design

Total Participants: 40
Treatment Group(s): 1
Primary Treatment: Tisleizumab(BGB-A317)
Phase: 2
Study Start date:
September 23, 2023
Estimated Completion Date:
December 31, 2025

Connect with a study center

  • Sun Yat-Sen University Cancer Center

    Guangzhou, Guangdong 510060
    China

    Active - Recruiting

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