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This study will evaluate the efficacy and safety of SHR-1701 combined with radiotherapy and chemotherapy as perioperative treatment for locally advanced rectal cancer. Eligible patients will receive standard chemoradiation with SHR-1701 followed by XELOX combined with SHR-1701. In all subjects, restaging pelvic MRI with chest and abdominal CT will be performed after completion of neoadjuvant treatment to determine resectability and to rule out any evidence of metastases. Subjects who have resectable disease will undergo surgery. Adjuvant XELOX combined with SHR-1701 will be given after surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Perioperative treatment | Experimental | Eligible subjects will receive standard chemoradiotherapy with SHR-1701 followed by XELOX combined with SHR-1701 and surgery. Adjuvant XELOX combined with SHR-1701 will be given after surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-1701ï¼›Capecitabineï¼›Oxaliplatin | Drug | Radiation: Radiation therapy 50.4Gy in 28 fractions to the pelvis on Days 1-5 every week. Drug: Capecitabine Capecitabine 825mg/m^2 orally twice daily (bid) 5 days/week during radiotherapy. Drug:SHR-1701 Drug: Capecitabine (XELOX) Capecitabine 1000mg/m^2 orally twice daily (bid) day1-day14, q3w. Drug: Oxaliplatin Oxaliplatin 130mg/m^2, day1, iv, q3w |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0 | At week 16, DAY1 | |
| Percentage of participants with Pathological complete response ( pCR ) | At week 16, DAY1 |
| Measure | Description | Time Frame |
|---|---|---|
| Tumor regression grade ( TRG ) | At week 16, DAY1 | |
| Percentage of participants with R0 Resection ( R0 ) | At week 16, DAY1 | |
| Percentage of participants with Clinical complete response ( cCR ) rate. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qing Yang, M.D | Contact | +86 021-61053363 | qing.yang@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Zhongshan Hospital | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40876501 | Derived | Tang W, Lv Y, Xie H, Wei Y, Wang J, Yu M, Jiang Y, Mao R, Huang C, Rao S, Ding K, Chang W, He G, Xu J. Efficacy and safety of SHR-1701 combined with chemoradiotherapy as neoadjuvant treatment for locally advanced rectal cancer. Cancer Lett. 2026 Jan 1;636:218006. doi: 10.1016/j.canlet.2025.218006. Epub 2025 Aug 26. |
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A multicenter, open, single-arm, two-stage phase II clinical study
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| At week 16, DAY1 |
| Event-free survival ( EFS ) | Year 1, Year 2, Year 3 |
| Overall survival ( OS ) | Year 1, Year 2, Year 3 |
| Disease-free survival ( DFS ) | Year 1, Year 2, Year 3 |