Trial Title:
Neoadjuvant Tisleizumab(BGB-A317) for dMMR/MSI-H Non-late Stage CRC Patients Before Surgery
NCT ID:
NCT06262581
Condition:
DMMR Colorectal Cancer
Anti PD-1
Immunotherapy
Conditions: Official terms:
Colorectal Neoplasms
Tislelizumab
Conditions: Keywords:
CRC
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Tisleizumab(BGB-A317)
Description:
200mg i.v. q3w
Arm group label:
dMMR/MSI-H stage I-III CRC patients
Other name:
surgery
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.
Criteria for eligibility:
Criteria:
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 after
last dose of immunotherapy
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 , cardiac
infarction 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Sun Yat-Sen University Cancer Center
Address:
City:
Guangzhou
Zip:
510060
Country:
China
Status:
Recruiting
Contact:
Last name:
Gong C Chen, Prof
Phone:
+862087343584
Email:
chengong@sysucc.org.cn
Investigator:
Last name:
Zhi-zhong Pan, Prof
Email:
Sub-Investigator
Investigator:
Last name:
Xiao-jun Wu, Prof
Email:
Sub-Investigator
Investigator:
Last name:
Zhen-hai Lu, Prof
Email:
Sub-Investigator
Investigator:
Last name:
Pei-rong Ding, Prof
Email:
Sub-Investigator
Investigator:
Last name:
Li-ren Li, Prof
Email:
Sub-Investigator
Investigator:
Last name:
Fu-long Wang, M.D.
Email:
Sub-Investigator
Investigator:
Last name:
Rong-xin Zhang, M.D.
Email:
Sub-Investigator
Investigator:
Last name:
Jian-hong Peng, M.D.
Email:
Sub-Investigator
Investigator:
Last name:
Jun-zhong Lin, M.D.
Email:
Sub-Investigator
Investigator:
Last name:
Ling-heng Kong, M.D.
Email:
Sub-Investigator
Investigator:
Last name:
Cong Li, M.D.
Email:
Sub-Investigator
Investigator:
Last name:
Wu Jiang, M.D.
Email:
Sub-Investigator
Investigator:
Last name:
Wen-hua Fan, M.D.
Email:
Sub-Investigator
Investigator:
Last name:
Wen-hao Zhou, M.D.
Email:
Sub-Investigator
Investigator:
Last name:
Jing-hua Tang, M.D.
Email:
Sub-Investigator
Investigator:
Last name:
Yuan Li, M.D.
Email:
Sub-Investigator
Investigator:
Last name:
Miaoqing Wu
Email:
Sub-Investigator
Investigator:
Last name:
Di Cao
Email:
Sub-Investigator
Investigator:
Last name:
Yi-fan Liu
Email:
Sub-Investigator
Investigator:
Last name:
Da Kang
Email:
Sub-Investigator
Start date:
September 23, 2023
Completion date:
December 31, 2025
Lead sponsor:
Agency:
Sun Yat-sen University
Agency class:
Other
Source:
Sun Yat-sen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06262581
