Neoadjuvant and Adjuvant Therapy Studies of Sintilimab Combined With Chemotherapy With or Without Ipilimumab N01 in Resectable Gastric/Gastroesophageal Junction Adenocarcinoma
A Randomized, Double-Blind, Phase II/III Clinical Study of the Efficacy and Safety of Sintilimab Combined With Chemotherapy With or Without Ipilimumab N01 in Perioperative Treatment of Resectable Gastric/Gastroesophageal Junction Adenocarcinoma
Studieoversigt
Status
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Fase 2
- Fase 3
Kontakter og lokationer
Studiekontakt
- Navn: Chunxian Hu
- Telefonnummer: +86 021 3183 7200
- E-mail: chunxian.hu@innoventbio.com
Studiesteder
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Guangdong
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Guangzhou, Guangdong, Kina, 510060
- Rekruttering
- Sun Yat-sen University Cancer Center
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Kontakt:
- Ruihua Xu
- Telefonnummer: 020-87343468
- E-mail: xurh@sysucc.org.cn
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-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria
- Signed written Informed Consent Form (ICF) and ability to comply with protocol-specified visits and related procedures.
- Age ≥ 18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
- Expected survival ≥ 6 months.
- Histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction (GEJ). For GEJ cancer, only Siewert type III and Siewert type II participants not requiring combined thoracotomy are eligible.
- Clinical stage T3-4Nany or TanyN+M0 (stage II-IVa) gastric/GEJ adenocarcinoma confirmed by endoscopic ultrasound or contrast-enhanced CT/MRI within 4 weeks before the first dose, per the American Joint Committee on Cancer (AJCC) 8th edition gastric cancer TNM staging system.
- Within 4 weeks before the first dose, evaluated by a responsible surgeon based on medical history and confirmed to meet study requirements for radical R0 resection.
Exclusion Criteria
- Histologically or cytologically confirmed other pathologic types (e.g., squamous cell carcinoma, sarcoma, undifferentiated carcinoma) or combined gastrointestinal stromal tumor (GIST) before randomization.
- Suspicious metastatic lesions or locally advanced unresectable disease, regardless of stage.
- History of gastrointestinal perforation or fistula within 6 months before randomization. May be enrolled if perforation/fistula has been surgically treated (repaired/resected) and disease recovery/remission is confirmed by the investigator.
- Active diverticulitis, intra-abdominal abscess, or gastrointestinal obstruction.
- Inability to swallow, malabsorption syndrome, or uncontrolled nausea/vomiting/diarrhea, or other severe gastrointestinal diseases affecting drug intake/absorption.
- Any life-threatening bleeding event within 3 months before randomization, or grade 3/4 gastrointestinal/variceal bleeding requiring endoscopic/surgical intervention.
- Active uncontrolled bleeding or known bleeding diathesis.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Sintilimab
Neoadjuvant Treatment period: up to 3 cycles of sintilimab plus chemotherapy in combination with Ipilimumab N01 prior to surgery. adjuvant Treatment period: Subjects will receive 5 cycles of sintilimab plus chemotherapy, and then receive sintilimab therapy after surgery until disease recurrence, unacceptable toxicity, receiving new anti-tumor therapy, withdrawal of informed consent (ICF), lost to follow-up or death, or other conditions that require treatment discontinuation (whichever occurs first). The maximum duration of postoperative treatment with either sintilimab or placebo is 13 cycles. |
40mg/m2, D1-14 BID PO Q3W
200mg D1 IV Q3W
130 mg/m2 D1 IV Q3W
1mg/kg, D1 IV Q6W
|
|
Eksperimentel: Sintilimab+Ipilimumab N01
Neoadjuvant Treatment period: up to 3 cycles of sintilimab plus chemotherapy in combination with Ipilimumab N01 prior to surgery. adjuvant Treatment period: Subjects will receive 5 cycles of sintilimab plus chemotherapy, and then receive sintilimab therapy after surgery until disease recurrence, unacceptable toxicity, receiving new anti-tumor therapy, withdrawal of informed consent (ICF), lost to follow-up or death, or other conditions that require treatment discontinuation (whichever occurs first). The maximum duration of postoperative treatment with either sintilimab or placebo is 13 cycles. |
40mg/m2, D1-14 BID PO Q3W
200mg D1 IV Q3W
130 mg/m2 D1 IV Q3W
1mg/kg, D1 IV Q6W
|
|
Aktiv komparator: Sintilimab placebo+Ipilimumab N01 placebo
Neoadjuvant Treatment period: up to 3 cycles of sintilimab placebo plus chemotherapy in combination with Ipilimumab N01 Placebo prior to surgery. adjuvant Treatment period: Subjects will receive 5 cycles of sintilimab placebo plus chemotherapy, and then receive sintilimab placebo therapy after surgery until disease recurrence, unacceptable toxicity, receiving new anti-tumor therapy, withdrawal of informed consent (ICF), lost to follow-up or death, or other conditions that require treatment discontinuation (whichever occurs first). The maximum duration of postoperative treatment with either sintilimab or placebo is 13 cycles. |
40mg/m2, D1-14 BID PO Q3W
130 mg/m2 D1 IV Q3W
1mg/kg, D1 IV Q6W
200 mg, D1 IV Q3W
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Major Pathological Response (MPR) rate in Resectable Gastric/Gastroesophageal Junction Adenocarcinoma
Tidsramme: Up to approximately 6 weeks following the beginning of Post-operative Assessment baseline(up to Study 2 years )
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The MPR rate is defined as the proportion of participants with a Tumor Regression Grade (TRG) score of 0 or 1 in the primary tumor after radical surgical resection following neoadjuvant therapy.
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Up to approximately 6 weeks following the beginning of Post-operative Assessment baseline(up to Study 2 years )
|
|
Event-Free Survival (EFS)
Tidsramme: Up to approximately 5 years
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The EFS is defined as the time from randomization to the first occurrence of disease progression precluding curative resection, postoperative local recurrence, distant metastasis, or death from any cause.
|
Up to approximately 5 years
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Samlet overlevelse (OS)
Tidsramme: Op til cirka 5 år
|
OS er defineret som tiden fra randomisering til død på grund af enhver årsag.
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Op til cirka 5 år
|
|
pathological Complete Response (pCR) rate
Tidsramme: Up to approximately 6 weeks following the beginning of Post-operative Assessment baseline(up to Study 2 years )
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The pCR rate is defined as the proportion of participants with no residual viable tumor in both the primary tumor and lymph nodes after radical surgical resection following neoadjuvant therapy.
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Up to approximately 6 weeks following the beginning of Post-operative Assessment baseline(up to Study 2 years )
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Clinical Down-staging Rate
Tidsramme: Up to approximately 6 weeks following the beginning of Post-operative Assessment baseline(up to Study 2 years )
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Clinical downstaging rate refers to the proportion of participants with a reduction in clinical TNM (cTNM) stage after neoadjuvant therapy.
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Up to approximately 6 weeks following the beginning of Post-operative Assessment baseline(up to Study 2 years )
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R0 resection rate
Tidsramme: Up to approximately 6 weeks following the beginning of Post-operative Assessment baseline(up to Study 2 years )
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The R0 resection rate is defined as the proportion of participants who underwent R0 resection.
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Up to approximately 6 weeks following the beginning of Post-operative Assessment baseline(up to Study 2 years )
|
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numbers of subjects with adverse events
Tidsramme: Up to approximately 5 years
|
defined as any untoward medical occurrence, whether or not there is a causal relationship with the study drug, in a clinical study subject from the time informed consent form is signed
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Up to approximately 5 years
|
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numbers of subjects with serious adverse events
Tidsramme: Up to approximately 5 years
|
Defined as any serious untoward medical occurrence, whether or not there is a causal relationship with the study drug, in a clinical study subject from the time informed consent form is signed
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Up to approximately 5 years
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Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
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
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