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Trial Title:
The Combination of Immunotherapy and Neoadjuvant Short-course Radiotherapy in Early Rectal Cancer (TORCH-E）
NCT ID:
NCT05555888
Condition:
Early Low Rectal Cancer
Conditions: Official terms:
Rectal Neoplasms
Capecitabine
Oxaliplatin
Antibodies
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
PD-1 antibody
Description:
PD-1 antibody (Toripalimab): 240mg d1 q3w
Arm group label:
Treatment Arm
Other name:
Toripalimab
Intervention type:
Drug
Intervention name:
Capecitabine
Description:
Capecitabine: 1000mg/m2 d1-14 q3w
Arm group label:
Treatment Arm
Other name:
Xeloda
Intervention type:
Drug
Intervention name:
Oxaliplatin
Description:
Oxaliplatin: 130mg/m2 d1 q3w
Arm group label:
Treatment Arm
Intervention type:
Radiation
Intervention name:
Short-course radiotherapy
Description:
Shor-course radiotherapy: 25Gy/5Fx
Arm group label:
Treatment Arm
Summary:
The study evaluates the combination of immunotherapy of PD-1 antibody and neoadjuvant
short-course radiotherapy in early low rectal cancer. A total of 34 patients will receive
5*5Gy short-course radiotherapy, followed by 4 cycles of capecitabine plus oxaliplatin
(CAPOX) chemotherapy and PD-1 antibody, finally receive the local excision(TEM) or total
mesorectal excision (TME). The rate of complete response (CR, pCR + sustained cCR for ≥ 1
year), Organ retention rate, long-term prognosis, and adverse effects will be analyzed.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. age 18-70 years old, female and male
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:
1. pregnancy or breast-feeding women
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
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Fudan University Shanghai Cancer Center
Address:
City:
Shanghai
Zip:
200032
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhen Zhang, M.D, PH.D
Phone:
19521280960
Email:
zhen_zhang@fudan.edu.cn
Start date:
December 12, 2022
Completion date:
November 1, 2025
Lead sponsor:
Agency:
Fudan University
Agency class:
Other
Source:
Fudan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05555888
