Short-course Radiotherapy Combined With CAPOX and PD-1 Antibody Versus Long-course Chemoradiotherapy Combined With CAPOX for Early Low-lying Rectal Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Short-course radiotherapy, PD-1 antibody (Toripalimab), Long-course radiotherapy, Oxaliplatin.
- Who it may be relevant to
- Registry conditions: Early Low Rectal Cancer. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Prospective, Randomized, Phase II Trial of Short-course Radiotherapy Combined With CAPOX and PD-1 Antibody Versus Long-course Chemoradiotherapy Combined With CAPOX for Early Low-lying Rectal Cancer
Overview
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.
Interventions
- Radiation Short-course radiotherapy
Short-course radiotherapy: 25Gy/5Fx - Drug PD-1 antibody (Toripalimab)
Toripalimab 240mg d1 q3w - Radiation Long-course radiotherapy
Long-course radiation: 50Gy/25Fx - Drug Oxaliplatin
Oxaliplatin: 130mg/m2 d1 q3w - Drug Capecitabine
Xeloda
Primary outcome measures
- complete response (CR) rate [Time frame: 1 month after the surgery or the decision of W&W]
Secondary outcome measures (6)
- Grade 3-4 adverse effects rate [Time frame: From date of randomization until 3 months after the completion neoadjuvant therapy]
- Organ preservation rate [Time frame: from date of receiving neoadjuvant therapy, assessed up to 3 years]
- 3 year disease free survival rate [Time frame: From date of initiation of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months.]
- 3 year local recurrence free survival rate [Time frame: From date of initiation of treatment until the date of first documented pelvic failure, assessed up to 36 months.]
- 3 year overall survival rate [Time frame: From date of initiation of treatment until the date of death from any cause, assessed up to 36 months.]
- 3 year Quality of Life [Time frame: From date of initiation of treatment until the date of death from any cause, assessed up to 3 years]
Eligibility criteria
Inclusion criteria
- age 18-75 years old, female and male
- pathological confirmed adenocarcinoma
- clinical stage T1-3bN0-1, tumor maximum diameter less than 4cm
- the distance from anal verge less than 5 cm
- without distance metastases
- KPS >=70
- with good compliance
- microsatellite repair status is MSS/pMMR
- without previous anti-cancer therapy or immunotherapy
- signed the inform consent
Exclusion criteria
- pregnancy or breast-feeding women
- pathological confirmed signet ring cell carcinoma
- clinical stage T1N0 and can be resected locally
- history of other malignancies within 5 years
- serious medical illness, such as severe mental disorders, cardiac disease, uncontrolled infection, etc.
- immunodeficiency disease or long-term using of immunosuppressive agents
- 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
- DPD deficiency
- allergic to any component of the therapy
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Fudan University Shanghai Cancer Center — Shanghai
Identifiers
NCT: NCT06462053 · FDRT-2023-377-3496