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

Launched by SUN YAT-SEN UNIVERSITY · Feb 15, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating the use of a medication called Tisleizumab (an anti-PD-1 immunotherapy) as a treatment for patients with specific types of colorectal cancer (CRC) before they undergo surgery. The trial focuses on patients with dMMR/MSI-H non-late stage CRC, which means their cancer has certain genetic characteristics that may make it more responsive to this type of treatment. The trial aims to see how safe and effective Tisleizumab is in shrinking the tumors and preventing cancer from returning after surgery.

To participate in this trial, individuals must be at least 18 years old, have a confirmed diagnosis of dMMR/MSI-H CRC, and be in good overall health without previous treatments like chemotherapy or radiation. Participants will need to provide some blood samples and agree to follow trial requirements. If eligible, they can expect to receive Tisleizumab before their surgery, and the effects of the treatment will be closely monitored. It's important to know that there are specific health conditions and circumstances that might prevent someone from joining, such as having autoimmune diseases or other serious health issues.

Gender

ALL

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