Short-course Radiotherapy Followed by Tislelizumab + CapeOX in the Treatment for Locally Advanced Rectal Cancer
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- STATUS
- Recruiting
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- End date
- May 15, 2026
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- participants needed
- 100
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- sponsor
- Hebei Medical University Fourth Hospital
Summary
This study is a single-center, prospective, open-label, randomized controlled clinical study, and the purpose of this study was to compare the pathological complete response rate (PCR) of patients with locally advanced rectal cancer treated with short-course radiotherapy sequential Tislelizumab combined with CapeOX (group A) versus short-course radiotherapy sequential CapeOX (group B). A total of 100 patients with locally advanced rectal cancer will be enrolled in the study. These patients were randomly assigned to the experimental group (group A) and the control group (group B) in a ratio of 1:1.
Description
Subjects in group A will be treated according to the following treatment plan:
Standard SCRT: A total radiation dose of 25 Gy was delivered in 5 fractions (from day 1 to 5) Sequential treatment period: After resting for 5 days following completion of SCRT, patients were treated with Tislelizumab (days 11, 33, 55, 77) and neoadjuvant chemotherapy with CapeOX (days 11 to 25, 33 to 47, 55 to 69, and 77 to 91).
Surgery: Total mesorectal excision will be performed between day 98 and 105, i.e., between 1 to 2 weeks after completion of Sequential treatment) Postoperative adjuvant chemotherapy: Chemotherapy will be started 4-6 weeks after surgery, and the adjuvant regimen was CapeOX for 2 cycles.
Subjects in group B will be treated according to the following treatment plan:
Standard SCRT: A total radiation dose of 25 Gy was delivered in 5 fractions (from day 1 to 5) Sequential treatment period: After resting for 5 days following completion of SCRT, patients were treated with neoadjuvant chemotherapy with CapeOX (days 11 to 25, 33 to 47, 55 to 69, and 77 to 91).
Surgery: Total mesorectal excision will be performed between day 98 and 105, i.e., between 1 to 2 weeks after completion of Sequential treatment.
Postoperative adjuvant chemotherapy: Chemotherapy will be started 4-6 weeks after surgery, and the adjuvant regimen was CapeOX for 2 cycles.
The Primary endpoint of the study is Pathological complete response rate(PCR ) assessed by the blind independent review committee (BIRC), defined as the absence of viable tumour cells in the resected primary tumour specimen and all sampled regional lymph nodes (ypT0N0)
Details
| Condition | Locally Advanced Rectal Cancer |
|---|---|
| Treatment | tislelizumab, Short-course Radiotherapy, Capecitabine+Oxaliplatin |
| Clinical Study Identifier | NCT05086627 |
| Sponsor | Hebei Medical University Fourth Hospital |
| Last Modified on | 4 October 2022 |
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