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This study is a prospective phase II clinical trial aimed at exploring the potential benefits of supplementing β-hydroxybutyrate with existing short course radiotherapy sequential immunotherapy and CAPEOX therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| experimental group | Experimental | Radiotherapy (SCRT): Total dose 25 Gy delivered in 5 fractions (5 Gy per fraction, once daily over 5 consecutive days). β-hydroxybutyrate: Oral β-hydroxybutyrate supplement (5g/day, starting from the day of first radiotherapy, lasting for 2 weeks). Immunotherapy (PD-1 monoclonal antibody): 200 mg via intravenous infusion every 3 weeks (q3w) for 6 cycles, initiated 1 week after radiotherapy completion. Chemotherapy (CAPEOX regimen): Oxaliplatin: 130 mg/m² IV infusion over 120 minutes on Day 1. Capecitabine: 1000 mg/m² orally twice daily (morning and evening, 30 minutes after meals) on Days 1-14. Cycle duration: 3 weeks per cycle; total of 6 cycles during the neoadjuvant phase. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Short-course radiotherapy | Radiation | Eligible subjects will receive short-course radiotherapy (SCRT). One week after the end of treatment, subjects continued to receive neoadjuvant chemotherapy. |
| Measure | Description | Time Frame |
|---|---|---|
| complete response (CR) rate | Defined as pathological complete response (pCR) + Clinical complete response (cCR) | an expected average of 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 3-year disease-Free Survival | The time from the first day of disease free (operation date) to local or distant recurrence, or the death event caused by any reason, whichever occurs first | an expected average of 3 years |
| Overall Survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhenyu Lin, MD | Contact | 027-83262683 | whxhlzy@hust.edu.cn | |
| Tao Zhang, MD | Contact | whxhlzy@hust.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Zhenyu Lin | Huazhong University of Science and Technology Tongji Medical College Union Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Recruiting | Wuhan | Hubei | 430022 | China |
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| Capecitabine | Drug | 1000mg/m2, bid, po, d1-14,q3w |
|
| Oxaliplatin | Drug | 130mg/m2, ivgtt, d1,q3w |
|
| TME surgery | Procedure | The surgery was performed 1 week after the end of neoadjuvant therapy. |
|
| β-hydroxybutyrate | Dietary Supplement | Oral β-hydroxybutyrate supplement (5g/day, starting from the day of first radiotherapy, lasting for 2 weeks). |
|
The time from the date of randomization to the death caused by any cause
| an expected average of 5 years |
| Adverse events (AEs) were graded according to the NCI CTCAE version 5·0 | Adverse events and surgical safety | an expected average of 1.5 years |
| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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| ID | Term |
|---|---|
| D000069287 | Capecitabine |
| D000077150 | Oxaliplatin |
| ID | Term |
|---|---|
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
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