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Trial Title:
Short-course Radiotherapy Combined With CAPOX and PD-1 Antibody Versus Long-course Chemoradiotherapy Combined With CAPOX for Early Low-lying Rectal Cancer
NCT ID:
NCT06462053
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:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
Short-course radiotherapy
Description:
Short-course radiotherapy: 25Gy/5Fx
Arm group label:
Short-course Radiotherapy plus immunochemotherapy group
Other name:
SCRT
Intervention type:
Drug
Intervention name:
PD-1 antibody (Toripalimab)
Description:
Toripalimab 240mg d1 q3w
Arm group label:
Short-course Radiotherapy plus immunochemotherapy group
Other name:
Toripalimab
Intervention type:
Radiation
Intervention name:
Long-course radiotherapy
Description:
Long-course radiation: 50Gy/25Fx
Arm group label:
Long-course Radiotherapy plus chemotherapy group
Other name:
LCRT
Intervention type:
Drug
Intervention name:
Oxaliplatin
Description:
Oxaliplatin: 130mg/m2 d1 q3w
Arm group label:
Long-course Radiotherapy plus chemotherapy group
Arm group label:
Short-course Radiotherapy plus immunochemotherapy group
Intervention type:
Drug
Intervention name:
Capecitabine
Description:
Xeloda
Arm group label:
Long-course Radiotherapy plus chemotherapy group
Arm group label:
Short-course Radiotherapy plus immunochemotherapy group
Other name:
Xeloda
Summary:
TORCH-E2 is a prospective, multicentre, randomized phase II trial. 134 low-lying early
(T1-3b/N0-1M0, distance from anal verge ≤5cm) patients will be recruited and assigned to
Group 1 and Group 2 (1:1). Group 1 receives SCRT (25Gy/5Fx) followed by 4 cycles of
capecitabine plus oxaliplatin (CAPOX) chemotherapy and PD-1 antibody. Group 2 receives
LCRT (50Gy/25Fx) followed by 2 cycles of CAPOX. A WW option can be applied to patients
achieving cCR while surgery will be recommended for those who fail to achieve cCR. The
primary endpoint is complete response (CR, pathological complete response [pCR] plus cCR)
rate. The secondary endpoints include the grade 3-4 acute adverse effects (AE) rate, anal
preservation rate, 3-year DFS rate, etc.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. age 18-75 years old, female and male
2. pathological confirmed adenocarcinoma
3. clinical stage T1-3bN0-1, 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:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Fudan University Shanghai Cancer Center
Address:
City:
Shanghai
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhen Zhang, MD, PHD
Phone:
021-64175590
Email:
zhen_zhang@fudan.edu.cn
Start date:
April 1, 2024
Completion date:
March 1, 2027
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/NCT06462053
