Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06312982 | A Series of Neoadjuvant Chemoradiotherapy Combined With Immunotherapy for Locally Advanced Rectal Cancer | PHASE2 | RECRUITING | 375 | — | — | Mar 16, 2024 | Dec 1, 2026 | Jan 13, 2026 | 2 | China |
complete response rate=(number of pathological complete responses + number of clinical complete responses)/total number of patients
| Arm | Type | Description |
|---|---|---|
| Experimental group | EXPERIMENTAL | The enrolled patients will receive a long course of NCRT (50 Gy / 25f, capecitabine 850-1000 mg / m2, BID, PO, D1-D5, QW) within the first 5 weeks. In regard to tumor immunotherapy, enrolled patients will receive tislelizumab (200 mg, iv) on the first day at week 2,5, and 8 after initiation of radiotherapy. Thereafter, patients will be treated with two 14-day cycles of the CAPOX（Q 3 w; D1 oxaliplatin, 130mg/m2,iv.gtt; D1-D14, capecitabine, 850-1000mg / m2, BID, PO）regimen. Two CAOPX regimens were treated one week apart. Eight to 8-10 weeks after the completion of radiation therapy, patients will undergo multiple examinations, including colonoscopy and MRI. Subsequent treatment options will be determined by each center physician based on their clinical experience. |
| Control group | NO_INTERVENTION | This group required only 5 weeks of NCRT and two 14-day cycles of the CAPOX （Q 3 w; D1 oxaliplatin, 130mg/m2,iv.gtt; D1-D14, capecitabine, 850-1000mg / m2, BID, PO）regimen. |
| Name | Type | Description |
|---|---|---|
| Tislelizumab | DRUG | Enrolled patients will receive tislelizumab 3 times after initiation of radiotherapy. |
Inclusion Criteria: 1. Signed a written informed consent form and volunteered to join the study; 2. .Age: 18-75 years old, male or female; 3. Pathohistologically confirmed rectal adenocarcinoma, along with immunohistochemical results of pMMR or genetic test results of MSS; 4. The baseline clinical ...