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
調査の概要
状態
研究の種類
入学 (推定)
段階
- フェーズ2
- フェーズ 3
連絡先と場所
研究連絡先
- 名前：Chunxian Hu
- 電話番号：+86 021 3183 7200
- メール：chunxian.hu@innoventbio.com
研究場所
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Guangdong
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Guangzhou、Guangdong、中国、510060
- 募集
- Sun Yat-sen University Cancer Center
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コンタクト：
- Ruihua Xu
- 電話番号：020-87343468
- メール：xurh@sysucc.org.cn
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-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：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
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|
実験的：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
|
|
アクティブコンパレータ：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
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Major Pathological Response (MPR) rate in Resectable Gastric/Gastroesophageal Junction Adenocarcinoma
時間枠：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 )
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Event-Free Survival (EFS)
時間枠：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.
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Up to approximately 5 years
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
全生存期間 (OS)
時間枠：最長約5年
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OS は、ランダム化から何らかの原因で死亡するまでの時間として定義されます。
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最長約5年
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pathological Complete Response (pCR) rate
時間枠：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
時間枠：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
時間枠：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
時間枠：Up to approximately 5 years
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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
時間枠：Up to approximately 5 years
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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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協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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