Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032, China
Location status: Recruiting
Recruiting
NCT Number: NCT05555888
The Combination of Immunotherapy and Neoadjuvant Short-course Radiotherapy in Early Rectal Cancer
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 (cCR+pCR), Organ retention rate, long-term prognosis, and adverse effects will be analyzed.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year–70 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 18-70 years old, female and male
- pathological confirmed adenocarcinoma
- clinical stage T1-3bN0, 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
PD-1 antibody
DrugPD-1 antibody (Toripalimab): 240mg d1 q3w
Other names: Toripalimab
Capecitabine
DrugCapecitabine: 1000mg/m2 d1-14 q3w
Other names: Xeloda
Oxaliplatin
DrugOxaliplatin: 130mg/m2 d1 q3w
Short-course radiotherapy
RadiationShor-course radiotherapy: 25Gy/5Fx
Primary outcomes
-
complete response (CR) rate
Time frame: The status of cCR will be evaluated after the completion of neoadjuvant therapy. The pCR rate will be evaluated after surgery. The cCR patients who adopted W&W strategy will be included into the CR rate caluculation.
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
-
Organ preservation rate
Time frame: from date of receiving neoadjuvant therapy, assessed up to 2 years
Rate of patients who underwent organ preservation via WW or TEM after neoadjuvant therapy
-
Grade 3-4 adverse effects rate
Time frame: From date of initiation of treatment until the date of death from any cause, assessed up to 5 years
Rate of chemotherapy, radiotherapy and immunotherapy related adverse events
-
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
-
10 year Quality of Life
Time frame: From date of initiation of treatment until the date of death from any cause, assessed up to 10 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 Phase II Trial of Immunotherapy Combined With Short-course Radiotherapy in Early Low Rectal Cancer
Acronym: TORCH-E
Important dates
- Study start
- 2022
- Primary completion
- 2024
- Study completion
- 2025
- First posted
- Sep 27, 2022
- Registry last updated
- Jan 15, 2025
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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