- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07607210
A Clinical Study of SHR-1701 Combined With Chemotherapy for the Perioperative Treatment of Locally Advanced Resectable Siewert Type II Adenocarcinoma of the Esophagogastric Junction
Panoramica dello studio
Stato
Intervento / Trattamento
Tipo di studio
Iscrizione (Stimato)
Fase
- Fase 2
Contatti e Sedi
Contatto studio
- Nome: Ziqiang Tian
- Numero di telefono: 18531118000
- Email: tizq12@vip.163.com
Luoghi di studio
-
-
Hebei
-
Shijiazhuang, Hebei, Cina
- The Fourth Hospital of Hebei Medical University
-
Contatto:
- Ziqiang Tian
- Numero di telefono: +8618531118000
- Email: tizq12@vip.163.com
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
Inclusion Criteria:
1.Age:18-75 years old, male or female; 2.Pathologically confirmed Siewert Type II adenocarcinoma of the gastroesophageal junction; 3.Clinical stage cT3-4aN1-3M0; 4.Low to moderate HER2 expression or no expression (IHC 2+ and FISH- / IHC 1+ / IHC -); 5.Eastern Cooperative Oncology Group (ECOG) performance status of 0-1; 6.At least one measurable lesion (according to RECIST 1.1 criteria); 7.Expected survival ≥ 3 months; 8.Normal functioning of major organs, i.e. meeting the following criteria:
routine blood tests:
- HB≥90g/L;
- ANC≥1.5×109/L;
- PLT≥100×109/L;
biochemical examination:
- ALT and AST<2.5ULN(liver metastasis: ALT and AST<5ULN);
- TBIL≤1.5ULN;
- Creatinine ≤1.5ULN; 9.Left ventricular ejection fraction is >50%; 10.Women of childbearing potential must have a negative pregnancy test (serum or urine) within 14 days prior to enrollment and must agree to use appropriate contraception during the observation period and for 8 weeks following the last administration of the study drug; for men, they must be surgically sterilized or agree to use appropriate contraception during the observation period and for 8 weeks following the last administration of the study drug; 11. Participants were willing to join in this study, written informed consent, good adherence and co-operation with follow up.
Exclusion Criteria:
- Known signs of active bleeding from the lesion (except for a positive fecal occult blood test);
- Diagnosis of HER2-positive adenocarcinoma of the stomach or gastroesophageal junction;
- Cardia or pyloric obstruction;
- Currently participating in an interventional clinical trial, or having received treatment with another investigational drug or device within 4 weeks prior to the first dose;
- Known hypersensitivity to any monoclonal antibody or component of a chemotherapy agent (such as tegafur or albumin-bound paclitaxel) (history of Grade 3 or higher hypersensitivity reaction);
- Previous exposure to any anti-PD-1 or anti-PD-L1, PD-L2, CD137, or CTLA-4 antibody therapy, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways;
- Receipt of an attenuated live vaccine within 4 weeks prior to the first dose of study treatment, or planned administration during the study period;
- Use of immunosuppressants or systemic corticosteroids for immunosuppressive purposes within 14 days prior to the start of study treatment (dose > 10 mg/day of prednisone or other corticosteroids of equivalent potency);
- History of active autoimmune disease requiring systemic treatment within 2 years prior to the first dose;
- Congenital or acquired immunodeficiency (e.g., HIV infection);
- The investigator determines that the subject has other factors that may affect the study results or lead to the premature termination of the study, such as alcohol abuse, substance abuse, other serious illnesses (including mental disorders) requiring concomitant treatment, severe laboratory abnormalities, or family or social factors that may compromise the subject's safety;
- Pregnant or breastfeeding women;
- Evidence of medical history or disease that may interfere with trial results or prevent the subject from participating in the study throughout its duration, abnormal treatment or laboratory test results, or other circumstances deemed by the investigator to make the subject unsuitable for enrollment; or other potential risks identified by the investigator that render the subject unsuitable for participation in this study.
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: SHR-1701+SOX
SHR-1701: 1800mg, iv, d1, q3w; SOX: S-1:40 mg (BSA<1.25 m2) , 50 mg (BSA1.25-1.5 m2) , or 60 mg (BSA≥ 1.5 m2) , po bid d1-14; Oxaliplatin:130 mg/m2 IV D1;
|
SHR-1701: 1800mg, iv, d1, q3w; SOX: S-1:40 mg (BSA<1.25 m2) , 50 mg (BSA1.25-1.5 m2) , or 60 mg (BSA≥ 1.5 m2) , po bid d1-14; Oxaliplatin:130 mg/m2 IV D1;
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
pathological Complete Response(pCR)
Lasso di tempo: 1-year
|
No residual invasive cancer cells were found under microscopic examination of the resected tumor tissue and regional lymph node samples.
|
1-year
|
|
R0 resection rate
Lasso di tempo: 1-year
|
The tumor was completely removed during surgery, and microscopic examination of the resected tissue margins revealed no residual cancer cells.
|
1-year
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Major Pathological Response(MPR)
Lasso di tempo: 1-year
|
Following neoadjuvant therapy, the proportion of viable tumor cells observed under a microscope in the surgically resected specimen is ≤10%.
|
1-year
|
|
PFS(Progression-Free Survival)
Lasso di tempo: 3 years
|
The time from the start of treatment until tumor progression or death from any cause.
|
3 years
|
|
OS(Overall Survival )
Lasso di tempo: 3 years
|
Time from enrollment to death from any cause.
For subjects who were still alive at the time of the last follow-up, their overall survival was censored on the date of the last follow-up.
|
3 years
|
Collaboratori e investigatori
Investigatori
- Investigatore principale: Ziqiang Tian, Hebei Medical University Fourth Hospital
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
Altri numeri di identificazione dello studio
- AZL-EJC
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su SHR-1701+SOX
-
Jingdong ZhangReclutamentoAdenocarcinoma della giunzione gastroesofagea | Cancro gastrico (GC)Cina
-
Jiangsu HengRui Medicine Co., Ltd.RitiratoCancro polmonare non a piccole cellule
-
Jiangsu HengRui Medicine Co., Ltd.ReclutamentoCancro gastrico metastatico | Adenocarcinoma della giunzione gastroesofagea | Cancro gastrico avanzatoCina
-
Jiangsu HengRui Medicine Co., Ltd.ReclutamentoCarcinoma polmonare non a piccole cellule localmente avanzato o metastaticoCina
-
Jiangsu HengRui Medicine Co., Ltd.Non ancora reclutamentoSHR-1701 in combinazione con Famitinib in pazienti con carcinoma rinofaringeo ricorrente/metastaticoCarcinoma rinofaringeoCina
-
Shanghai Chest HospitalNon ancora reclutamento
-
Atridia Pty Ltd.Completato
-
Jiangsu HengRui Medicine Co., Ltd.Attivo, non reclutante
-
Jiangsu HengRui Medicine Co., Ltd.Reclutamento
-
Jiangsu HengRui Medicine Co., Ltd.Reclutamento