Clinical trial · Interventional
Neoadjuvant Tisleizumab(BGB-A317) for dMMR/MSI-H Non-late Stage CRC Patients Before Surgery
Neoadjuvant Tisleizumab(BGB-A317) for dMMR/MSI-H Non-late Stage Colorectal Cancer Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anti PD-1 | — | UNRESOLVED | — |
| DMMR Colorectal Cancer | dMMR Colorectal Carcinoma | ALIAS | 0.90 |
| Immunotherapy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Tisleizumab(BGB-A317) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- dMMR/MSI-H stage I-III CRC patients
- description
- 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.
- interventionNames
- Drug: Tisleizumab(BGB-A317)
Primary outcomes (1)
- measure
- pathological complete regression rate
- timeFrame
- From enrollment to 1 year after surgery
- description
- Patients without noninvasive or focal-invasive residues or involved lymph nodes should be considered as having achieved pCR. The rate is these patients over the whole group.
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available