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.
Studieoversigt
Status
Betingelser
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Fase 3
Kontakter og lokationer
Studiekontakt
- Navn: Zhen Zhang, M.D, PH.D
- Telefonnummer: 18801735029
- E-mail: zhen_zhang@fudan.edu.cn
Undersøgelse Kontakt Backup
- Navn: Yajie Chen Chen, PH.D
- Telefonnummer: 18917239680
- E-mail: 16111230008@fudan.edu.cn
Studiesteder
-
-
Shanghai Municipality
-
Shanghai, Shanghai Municipality, Kina, 200030
- Fudan University Shanghai Cancer Center
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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
Andre navne:
Oxaliplatin: 130mg/m2 d1 q3w Xeloda |
|
Andet: 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 |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
3 year TME-free survival rate
Tidsramme: 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.
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
3 year local recurrence free survival rate
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Organiske kemikalier
- Heterocykliske forbindelser, 1-ring
- Heterocykliske forbindelser
- Nukleinsyrer, nukleotider og nukleosider
- Koordinationskomplekser
- Deoxycytidin
- Cytidin
- Pyrimidin -nukleosider
- Pyrimidiner
- Nukleosider
- Uracil
- Pyrimidinoner
- Deoxyribonucleosider
- Fluorouracil
- Capecitabin
- Oxaliplatin
- SINTILIMAB
Andre undersøgelses-id-numre
- FDRT-2026-388-5240
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .