Perioperative Fruquintinib Combined With Sintilimab and SOX for Locally Advanced Gastric or GEJ Adenocarcinoma
Perioperative Fruquintinib Combined With Sintilimab and SOX Versus Sintilimab and SOX for Resectable Locally Advanced Gastric/Gastroesophageal Junction Adenocarcinoma：A Multicenter,Open-label, Randomized Controlled Phase II Clinical Study
The purpose of this clinical trial is to evaluate whether perioperative fruquintinib combined with sintilimab and SOX is effective in treating locally advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma. The study will also assess the safety profile of this treatment regimen.
Primary Objective:
To determine whether perioperative fruquintinib combined with sintilimab and SOX improves the pathological complete response (pCR) rate compared with sintilimab plus SOX in patients with locally advanced gastric or GEJ adenocarcinoma.
Study Design:
Participants will be randomly assigned to receive either fruquintinib combined with sintilimab and SOX or sintilimab plus SOX to evaluate the potential added benefit of fruquintinib in this setting.
Participation Details:
Participants will receive the assigned treatment (fruquintinib combined with sintilimab and SOX or sintilimab plus SOX) every 21 days for approximately 3 months.
They will visit the clinic once every 3 weeks for evaluations, laboratory tests, and monitoring.
Participants will be asked to keep a daily diary to record any symptoms or side effects experienced during the study.
調査の概要
研究の種類
入学 (推定)
段階
- フェーズ2
連絡先と場所
研究連絡先
- 名前：Hongfeng Gou, PhD
- 電話番号：+86-18980602292
- メール：gouhongfeng1977@wchscu.cn
研究連絡先のバックアップ
- 名前：Wen Nie, Ph.D
- 電話番号：+86-02885423297
- メール：wennie1228@gmail.com
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:
- Age 18-75 years.
- Histologically confirmed gastric or gastroesophageal junction (G/GEJ) adenocarcinoma.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- Clinically staged as T3-4a N0-3M0 by computed tomography (CT) or magnetic resonance imaging (MRI).
- Considered eligible for curative resection.
- No prior antitumor therapy for the current disease.
- Adequate organ function, including hepatic, renal, and bone marrow function, as per prespecified laboratory criteria.
- Expected survival of ≥6 months.
Exclusion Criteria:
- Known mismatch repair-deficient (dMMR) or microsatellite instability-high (MSI-H) tumor.
- Uncontrolled hypertension, defined as systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥ 90 mmHg despite optimized antihypertensive therapy, or hypertension complicated by acute events (e.g., hypertensive crisis, hypertensive encephalopathy) that cannot be stably controlled.
- Tumor lesions with a bleeding tendency, including but not limited to: active ulcerative tumor lesions, hematemesis within 2 months prior to informed consent, high risk of major gastrointestinal bleeding as determined by the investigator.
- History of thromboembolic or arterial/venous vascular events within 6 months prior to enrollment, such as cerebrovascular events (including transient ischemic attack), deep vein thrombosis, or pulmonary embolism.
- Gastrointestinal perforation or gastrointestinal obstruction within 6 months prior to enrollment.
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：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Fruquintinib + Sintilimab + SOX
|
Fruquintinib, 4mg po d1-14 q3w, four 3-week cycles were administered; S-1 (administered orally twice daily on days 1-14 of each 21-day cycle, with the daily dose determined by body surface area: <1.25 m², 80 mg/day; ≥1.25 to <1.5 m², 100 mg/day; ≥1.5 m², 120 mg/day), four 3-week cycles were administered. Oxaliplatin (130 mg/m², administered intravenously on day 1), four 3-week cycles were administered. |
|
アクティブコンパレータ：Sintilimab + SOX
|
S-1 (administered orally twice daily on days 1-14 of each 21-day cycle, with the daily dose determined by body surface area: <1.25 m², 80 mg/day; ≥1.25 to <1.5 m², 100 mg/day; ≥1.5 m², 120 mg/day), four 3-week cycles were administered. Oxaliplatin (130 mg/m², administered intravenously on day 1), four 3-week cycles were administered. |
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 |
|---|---|---|
|
Total pathological complete response (pCR)
時間枠：Perioperative
|
Total pathological complete response (pCR; ypT0) assessed by investigators, defined as the complete absence of tumor cells in the primary tumor on pathological examination.
|
Perioperative
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Event-free survival (EFS)
時間枠：Through study completion, an average of 2 years
|
Event-free survival (EFS), defined as the time from randomization to the first occurrence of relapse, metastasis, or death from any cause;
|
Through study completion, an average of 2 years
|
|
TRAEs
時間枠：Through study completion,an average of 2 years
|
Treatment-related adverse events (TRAEs) with potential immunologic etiology were categorized and graded according to the Common Terminology Criteria for Adverse Events (CTCAE) (Version 5.0)
|
Through study completion,an average of 2 years
|
|
major pathologic response（MPR)
時間枠：Perioperative
|
major pathologic response（MPR) defined as ≤10% residual viable tumor cells in the resected primary tumor specimen after neoadjuvant therapy;
|
Perioperative
|
|
R0 resection
時間枠：Perioperative
|
R0 resection defined as microscopically margin-negative resection
|
Perioperative
|
|
overall survival (OS)
時間枠：Through study completion,an average of 2 years
|
OS defined as the time from randomization to death from any cause;
|
Through study completion,an average of 2 years
|
|
Expression of Predictive Biomarkers Associated With Treatment Response
時間枠：Baseline through study completion, an average of 2 years
|
Predictive biomarkers including PD-L1 expression, Epstein-Barr virus status, tumor mutational burden, and immune-related biomarkers will be analyzed for association with pathological and radiographic treatment response.
|
Baseline through study completion, an average of 2 years
|
|
Change in Quality of Life Assessed by EORTC QLQ-C30
時間枠：Through study completion, an average of 2 years
|
Quality of life was assessed using the EORTC QLQ-C30 questionnaires, administered at three time points: within one week before initiation of neoadjuvant therapy, within one week before the fourth neoadjuvant therapy cycle, and at 30 days postoperatively (±3 days)
|
Through study completion, an average of 2 years
|
|
disease-free survival (DFS)
時間枠：From date of post-surgery until the date of first occurrence of relapse, metastasis, or date of death from any cause, whichever came first, assessed up to 100 months
|
DFS defined as the time from the post-surgery baseline scan to the first occurrence of relapse, metastasis, or death from any cause
|
From date of post-surgery until the date of first occurrence of relapse, metastasis, or date of death from any cause, whichever came first, assessed up to 100 months
|
|
Change in Quality of Life Assessed by EORTC QLQ-STO22
時間枠：Through study completion, an average of 2 years
|
Quality of life was assessed using the EORTC QLQ-STO22 questionnaires, administered at three time points: within one week before initiation of neoadjuvant therapy, within one week before the fourth neoadjuvant therapy cycle, and at 30 days postoperatively (±3 days).
|
Through study completion, an average of 2 years
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Hongfeng Gou, Ph.D、Gastric Cancer Center, West China Hospital, Sichuan University, 37 Guoxue Alley, Chengdu 610041, Sichuan, China.
研究記録日
主要日程の研究
研究開始 (推定)
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
本研究に関する用語
キーワード
その他の研究ID番号
- HUAXI-GC
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。