SCRT Combined With CAPOX and PD-1/CTLA4 Antibody for Early-stage Low Rectal Cancer
The Combination of PD-1/CTLA4 Antibody and Neoadjuvant Short-course Radiotherapy in Early-stage Low Rectal Cancer
The study evaluates the combination of immunotherapy of PD-1/ CTLA4 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/ CTLA4 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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Stimato)
Fase
- Fase 2
Contatti e Sedi
Contatto studio
- Nome: Zhen Zhang, M.D, PH.D
- Numero di telefono: 18801735029 18801735029
- Email: zhen_zhang@fudan.edu.cn
Luoghi di studio
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Cina, 200030
- Fudan University Shanghai Cancer Center
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- age 18-75 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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Treatment Arm
A total of 34 patients will receive 5*5Gy short-course radiotherapy, followed by 4 cycles of CAPOX chemotherapy and PD-1/CTLA4 antibody, finally receive the TEM or TME surgery. |
Shor-course radiotherapy: 25Gy/5Fx Iparomlimab and Tuvonralimab, 5mg/kg, d1 q3w Capecitabine: 1000mg/m2 d1-14 q3w 130mg/m2 d1 q3w |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
complete response (CR) rate
Lasso di tempo: From date of receiving neoadjuvant therapy, assessed up to 2 years
|
Rate of complete response (CR), including the rate of pathologic complete response (pCR) after surgery and the rate of cCR with W&W strategy. |
From date of receiving neoadjuvant therapy, assessed up to 2 years
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Organ preservation rate
Lasso di tempo: 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 |
From date of receiving neoadjuvant therapy, assessed up to 2 years
|
|
3 year disease free survival rate
Lasso di tempo: 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 local recurrence free survival rate
Lasso di tempo: 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.
|
|
3 year overall survival rate
Lasso di tempo: 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.
|
|
10 year Quality of Life
Lasso di tempo: From date of initiation of treatment until the date of death from any cause, assessed up to 10 years
|
Patient self-assessment via EORTC QLQ-C30 questionnaire to monitor changes in quality of life throughout treatment. |
From date of initiation of treatment until the date of death from any cause, assessed up to 10 years
|
|
Grade 3-4 adverse effects rate
Lasso di tempo: From date of initiation of treatment until the date of death from any cause, assessed up to 5 years
|
Incidence and severity of treatment side effects graded by NCI CTCAE v5.0. |
From date of initiation of treatment until the date of death from any cause, assessed up to 5 years
|
Collaboratori e investigatori
Sponsor
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- FDRT-2026-306-5158
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