Using Tisleizumab before surgery for certain colorectal cancer patients
Neoadjuvant Tisleizumab(BGB-A317) for dMMR/MSI-H Non-late Stage Colorectal Cancer Patients
This study is testing if the immunotherapy Tisleizumab can help certain colorectal cancer patients before surgery to improve their chances of recovery and prevent the cancer from coming back.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sun Yat-sen University Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, Pembrolizumab, Nivolumab, Ipilimumab, Tisleizumab |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT06262581 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of Tisleizumab (BGB-A317), an anti-PD-1 immunotherapy, as a neoadjuvant treatment for patients with dMMR/MSI-H non-late stage colorectal cancer (CRC) prior to surgical intervention. The study aims to assess the efficacy of this immunotherapy in preventing cancer recurrence and improving surgical outcomes. Eligible participants must be adults with specific tumor characteristics and no prior treatment history, and they will undergo assessments to monitor their response to the therapy. The trial is conducted at Sun Yat-sen University Cancer Center in Guangzhou, Guangdong.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with dMMR/MSI-H colorectal cancer who have not received prior chemotherapy, radiotherapy, or immunotherapy.
Not a fit: Patients with autoimmune diseases, severe allergies to monoclonal antibodies, or uncontrolled comorbidities such as hypertension or diabetes may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve surgical outcomes and reduce the risk of cancer recurrence in patients with high-risk colorectal cancer.
How similar studies have performed: Other studies have shown promising results with similar immunotherapy approaches in treating advanced colorectal cancer, indicating potential for success in this neoadjuvant setting.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Guangzhou, Guangdong
- Sun Yat-Sen University Cancer Center — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Principal investigator: Gong Chen, Prof — Sun Yat-sen University
- Study coordinator: Gong Chen, Prof
- Email: chengong@sysucc.org.cn
- Phone: +86 020 87343584
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.