Fudan University Shanghai Cancer Center
Shanghai, China
Location status: Recruiting
Recruiting
NCT Number: NCT06462053
Short-course Radiotherapy Combined With CAPOX and PD-1 Antibody Versus Long-course Chemoradiotherapy Combined With CAPOX for Early Low-lying Rectal Cancer
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year–75 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 2
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Short-course radiotherapy
RadiationShort-course radiotherapy: 25Gy/5Fx
Other names: SCRT
PD-1 antibody (Toripalimab)
DrugToripalimab 240mg d1 q3w
Other names: Toripalimab
Long-course radiotherapy
RadiationLong-course radiation: 50Gy/25Fx
Other names: LCRT
Oxaliplatin
DrugOxaliplatin: 130mg/m2 d1 q3w
Capecitabine
DrugXeloda
Other names: Xeloda
Primary outcomes
-
complete response (CR) rate
Time frame: 1 month after the surgery or the decision of W&W
Rate of complete response (CR), including the rate of pathologic complete response (pCR) after surgery and the rate of cCR with W&W strategy.
Secondary outcomes
-
Grade 3-4 adverse effects rate
Time frame: From date of randomization until 3 months after the completion neoadjuvant therapy
Rate of chemotherapy, radiotherapy and immunotherapy related adverse events
-
Organ preservation rate
Time frame: from date of receiving neoadjuvant therapy, assessed up to 3 years
Organ preservation rate
-
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.
Rate of 3 year disease free survival
-
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.
Rate of 3 year local recurrence free survival
-
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.
Rate of 3 year overall survival
-
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
Quality of life will be evaluated using EORTC QLQ-C30, EORTC QLQ-CR29, LARS score and Wexner score.
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Fudan University
Other
Registry information
Official study 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
Acronym: TORCH-E2
Important dates
- Study start
- 2024
- Primary completion
- 2026
- Study completion
- 2027
- First posted
- Jun 17, 2024
- Registry last updated
- Jun 17, 2024
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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