SCRT Combined With CAPOX and PD-1 Antibody Versus LCRT Combined With CAPOX for Early Low-lying Rectal Cancer (TORCH-E3) (TORCH-E3)
A Prospective, Randomized, Phase III Clinical Trial Comparing Short-course Radiotherapy Combined With CAPOX and PD-1 Monoclonal Antibody Versus Long-course Chemoradiotherapy Combined With CAPOX for the Treatment of Early-stage Low Rectal Cancer.
TORCH-E3 is a prospective, multicentre, randomized phase III trial. 394 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 3y TME-free survival. The secondary endpoints include complete response (CR, pathological complete response [pCR] plus cCR) rate, the grade 3-4 acute adverse effects (AE) rate, anal preservation rate, 3-year DFS rate, etc.
Studieöversikt
Status
Betingelser
Studietyp
Inskrivning (Beräknad)
Fas
- Fas 3
Kontakter och platser
Studiekontakt
- Namn: Zhen Zhang, M.D, PH.D
- Telefonnummer: 18801735029
- E-post: zhen_zhang@fudan.edu.cn
Studera Kontakt Backup
- Namn: Yajie Chen Chen, PH.D
- Telefonnummer: 18917239680
- E-post: 16111230008@fudan.edu.cn
Studieorter
-
-
Shanghai Municipality
-
Shanghai, Shanghai Municipality, Kina, 200030
- Fudan University Shanghai Cancer Center
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: SCRT plus immunochemotherapy group
Patients will receive SCRT (25Gy/5Fx, SCRT), followed by 4 cycles of CAPOX and PD-1 antibody, finally receive the TEM or TME surgery or adopt WW option. |
SCRT: 25Gy/5Fx Sintilimab 200mg d1 q3w
Andra namn:
Oxaliplatin: 130mg/m2 d1 q3w Xeloda |
|
Övrig: LCRT plus chemotherapy group
Patients will receive LCRT (50Gy/25Fx,LCRT, concurrent capecitabine), followed by 2 cycles of CAPOX, finally receive the TEM or TME surgery or adopt WW option. |
Oxaliplatin: 130mg/m2 d1 q3w Xeloda LCRT: 50Gy/25Fx |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
3 year TME-free survival rate
Tidsram: the proportion of patients who remain alive and have not undergone total mesorectal excision (TME) surgery within three years from the start of treatment.
|
Rate of 3 year TME-free survival |
the proportion of patients who remain alive and have not undergone total mesorectal excision (TME) surgery within three years from the start of treatment.
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
3 year local recurrence free survival rate
Tidsram: 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 |
From date of initiation of treatment until the date of first documented pelvic failure, assessed up to 36 months.
|
|
complete response (CR) rate
Tidsram: 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. |
1 month after the surgery or the decision of W&W
|
|
Organ preservation rate
Tidsram: from date of receiving neoadjuvant therapy, assessed up to 3 years
|
Organ preservation rate |
from date of receiving neoadjuvant therapy, assessed up to 3 years
|
|
3 year disease free survival rate
Tidsram: 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 |
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 overall survival rate
Tidsram: 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 |
From date of initiation of treatment until the date of death from any cause, assessed up to 36 months
|
|
3 year Quality of Life
Tidsram: 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 score. |
From date of initiation of treatment until the date of death from any cause, assessed up to 3 years
|
|
Grade 3-4 adverse effects rate
Tidsram: From date of randomization until 3 months after the completion neoadjuvant therapy
|
Rate of chemotherapy, radiotherapy and immunotherapy related adverse events |
From date of randomization until 3 months after the completion neoadjuvant therapy
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Organiska kemikalier
- Heterocykliska föreningar, 1-ring
- Heterocykliska föreningar
- Nukleinsyror, nukleotider och nukleosider
- Koordinationskomplex
- Deoxycytidin
- Cytidin
- Pyrimidin nukleosider
- Pyrimidiner
- Nukleosider
- Uracil
- Pyrimidinoner
- Deoxyribonukleosider
- Fluorouracil
- Capecitabin
- Oxaliplatin
- sintilimab
Andra studie-ID-nummer
- FDRT-2026-388-5240
Läkemedels- och apparatinformation, studiedokument
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