The Combination of Immunotherapy and Neoadjuvant Short-course Radiotherapy in Early Rectal Cancer
NCT ID: NCT05555888
Last Updated: 2025-01-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
34 participants
INTERVENTIONAL
2022-12-12
2025-05-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment Arm
A total of 34 patients will receive 5\*5Gy short-course radiotherapy, followed by 4 cycles of CAPOX chemotherapy and PD-1 antibody, finally receive the TEM or TME surgery.
PD-1 antibody
PD-1 antibody (Toripalimab): 240mg d1 q3w
Capecitabine
Capecitabine: 1000mg/m2 d1-14 q3w
Oxaliplatin
Oxaliplatin: 130mg/m2 d1 q3w
Short-course radiotherapy
Shor-course radiotherapy: 25Gy/5Fx
Interventions
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PD-1 antibody
PD-1 antibody (Toripalimab): 240mg d1 q3w
Capecitabine
Capecitabine: 1000mg/m2 d1-14 q3w
Oxaliplatin
Oxaliplatin: 130mg/m2 d1 q3w
Short-course radiotherapy
Shor-course radiotherapy: 25Gy/5Fx
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. pathological confirmed adenocarcinoma
3. clinical stage T1-3bN0, tumor maximum diameter less than 4cm
4. the distance from anal verge less than 5 cm
5. without distance metastases
6. KPS \>=70
7. with good compliance
8. microsatellite repair status is MSS/pMMR
9. without previous anti-cancer therapy or immunotherapy
10. signed the inform consent
Exclusion Criteria
2. pathological confirmed signet ring cell carcinoma
3. clinical stage T1N0 and can be resected locally
4. history of other malignancies within 5 years
5. serious medical illness, such as severe mental disorders, cardiac disease, uncontrolled infection, etc.
6. immunodeficiency disease or long-term using of immunosuppressive agents
7. baseline blood and biochemical indicators do not meet the following criteria: neutrophils≥1.5×10\^9/L, Hb≥90g/L, PLT≥100×10\^9/L, ALT/AST ≤2.5 ULN, Cr≤ 1 ULN
8. DPD deficiency
9. allergic to any component of the therapy
18 Years
70 Years
ALL
No
Sponsors
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Fudan University
OTHER
Responsible Party
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Zhen Zhang
Professor
Locations
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Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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References
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Chen Y, Wang Y, Zhang H, Wan J, Shen L, Wang Y, Zhou M, Wu R, Yang W, Zhou S, Cai S, Li X, Zhang Z, Xia F. Short-course radiotherapy combined with chemotherapy and PD-1 inhibitor in low-lying early rectal cancer: study protocol for a single-arm, multicentre, prospective, phase II trial (TORCH-E). BMJ Open. 2023 Oct 6;13(10):e076048. doi: 10.1136/bmjopen-2023-076048.
Other Identifiers
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FDRT-2022-227-2945
Identifier Type: -
Identifier Source: org_study_id
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