Retlirafusp Alfa Combined With Apatinib and Nab-Paclitaxel as Second-line Treatment for Gastric or Gastroesophageal Junction Cancer (RA-A-NP)
2026年5月25日 更新者：Henan Cancer Hospital
Retlirafusp Alfa Combined With Apatinib and Nab-Paclitaxel as Second-line Treatment for Patients With Immunotherapy-Pretreated Gastric or Gastroesophageal Junction Cancer: A Prospective, Single-Arm Clinical Study
This is a prospective, single-arm, investigator-initiated phase II clinical study.
The study evaluates the efficacy and safety of retlirafusp alfa (a PD-L1/TGF-βRII bifunctional fusion protein) combined with apatinib (a VEGFR-2 tyrosine kinase inhibitor) and nab-paclitaxel in patients with locally advanced unresectable, locally recurrent, or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma who have progressed after first-line immunotherapy-containing treatment.
調査の概要
詳細な説明
Gastric cancer is one of the most common malignant tumors of the digestive system.
For patients with advanced gastric cancer who have failed first-line immunotherapy plus chemotherapy, second-line treatment options remain limited.
Retlirafusp alfa is a bifunctional fusion protein targeting PD-L1 and TGF-βRII.
Apatinib is a small-molecule anti-angiogenic agent.
Nab-paclitaxel is a chemotherapeutic agent recommended for second-line treatment of advanced gastric cancer.
This prospective, single-arm study investigates the efficacy and safety of this triple combination regimen in immunotherapy-pretreated advanced second-line gastric or gastroesophageal junction adenocarcinoma, to provide a new therapeutic option for these patients.
研究の種類
介入
入学 (推定)
50
段階
- フェーズ2
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Ying Liu
- 電話番号：+86 13783604602
- メール：yaya7207@126.com
研究連絡先のバックアップ
- 名前：Ying Liu
- 電話番号：+8613783604602
- メール：yaya7207@126.com
研究場所
-
-
Henan
-
Zhengzhou、Henan、中国
- Henan Cancer Hospital
-
コンタクト：
- Henan Cancer Hospital
- 電話番号：0371-65587418
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
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
いいえ
説明
Inclusion Criteria:
- Able to provide written informed consent prior to any study-specific procedures
- Age ≥ 18 years
- ECOG performance status 0 or 1
- Histologically or cytologically confirmed gastric adenocarcinoma or gastroesophageal junction adenocarcinoma, locally advanced unresectable, locally recurrent, or metastatic
- Human epidermal growth factor receptor 2 (HER2) negative
- Failed first-line immunotherapy-containing systemic treatment
- At least one measurable lesion per RECIST Version 1.1
- Adequate organ function:
1)Hemoglobin ≥ 90 g/L 2)Absolute neutrophil count ≥ 1.5 × 10⁹/L 3)Platelet count ≥ 80 × 10⁹/L 4)Total bilirubin < 1.5 × upper limit of normal (ULN) 5)ALT/AST < 2.5 × ULN; < 5 × ULN in patients with liver metastasis 6)Serum creatinine ≤ 1.5 × ULN or creatinine clearance > 60 mL/min 7)Urine protein < 2+ or 24-hour urine protein < 1 g 8)Left ventricular ejection fraction (LVEF) ≥ 50% 9)Coagulation function: INR ≤ 1.5 × ULN, APTT ≤ 1.5 × ULN 8.Fertile male and female subjects must agree to use highly effective contraception during the study and for 6 months after the last dose of study treatment; female subjects must have a negative pregnancy test within 7 days before enrollment
Exclusion Criteria:
- Known hypersensitivity to any component of the study drugs
- Prior treatment with any VEGFR inhibitor (including apatinib, sorafenib, sunitinib)
- Prior treatment with retlirafusp alf
- Received any investigational drug within 4 weeks before first dose
- Received systemic corticosteroid (> 10 mg prednisone equivalent daily) or other immunosuppressive agents within 2 weeks before first dose, except for allowed topical/inhaled use or physiological replacement
- Active autoimmune disease or history of autoimmune disease (except controlled hypothyroidism, type 1 diabetes with stable insulin, vitiligo, resolved childhood asthma)
- Known immunodeficiency (including HIV infection), organ transplantation, or allogeneic hematopoietic stem cell transplantation
- Uncontrolled cardiac disease: NYHA Class ≥ II heart failure, unstable angina, myocardial infarction within 1 year, clinically significant arrhythmia requiring intervention
- Severe infection (CTCAE Grade > 2) within 4 weeks before first dose; active pulmonary infection, interstitial lung disease, non-infectious pneumonitis, pulmonary fibrosis; active tuberculosis
- Active hepatitis B (HBV DNA ≥ 2000 IU/mL) or active hepatitis C (HCV RNA positive)
- History of other malignancy within 5 years before enrollment, except adequately treated basal cell carcinoma, squamous cell carcinoma of skin, or carcinoma in situ of cervix
- Pregnant or lactating women
- Unwilling or unable to comply with study procedures
- Any other condition deemed inappropriate by the investigator
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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：なし
- 介入モデル：単一グループの割り当て
- 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：Retlirafusp alfa + Apatinib + Nab-paclitaxel
|
Retlirafusp alfa: 1800 mg, intravenous infusion, day 1, every 3 weeks; until disease progression, unacceptable toxicity, or withdrawal; maximum 2 years Apatinib: 250 mg, oral, once daily; until disease progression, unacceptable toxicity, or withdrawal Nab-paclitaxel: 260 mg/m², intravenous infusion, day 1, every 3 weeks; for 4-6 cycles
|
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 |
|---|---|---|
|
Objective Response Rate (ORR)
時間枠：From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months after the last subject enrolled
|
Proportion of patients achieving complete response (CR) or partial response (PR) per RECIST 1.1 criteria, assessed every 6 weeks
|
From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months after the last subject enrolled
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Disease Control Rate (DCR)
時間枠：From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months after the last subject enrolled
|
Proportion of patients achieving CR, PR, or stable disease (SD) per RECIST 1.1
|
From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months after the last subject enrolled
|
|
Progression-Free Survival (PFS)
時間枠：From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months after the last subject enrolled
|
Time from enrollment to disease progression or death from any cause
|
From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months after the last subject enrolled
|
|
Overall Survival (OS)
時間枠：From date of enrollment until the date of death from any cause, assessed up to 12 months after the last subject enrolled
|
Time from enrollment to death from any cause
|
From date of enrollment until the date of death from any cause, assessed up to 12 months after the last subject enrolled
|
|
Duration of Response (DoR)
時間枠：From first response to progression or death, up to 10 months after the last subject enrolled
|
Time from first documented response to disease progression or death
|
From first response to progression or death, up to 10 months after the last subject enrolled
|
|
Incidence and severity of adverse events (AEs)
時間枠：From informed consent until 30 days after last dose, assessed up to 7 months after the last subject enrolled
|
Incidence and severity of adverse events per NCI CTCAE v5.0
|
From informed consent until 30 days after last dose, assessed up to 7 months after the last subject enrolled
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年5月5日
一次修了 (推定)
2028年12月31日
研究の完了 (推定)
2029年6月30日
試験登録日
最初に提出
2026年5月14日
QC基準を満たした最初の提出物
2026年5月25日
最初の投稿 (実際)
2026年5月28日
学習記録の更新
投稿された最後の更新 (実際)
2026年5月28日
QC基準を満たした最後の更新が送信されました
2026年5月25日
最終確認日
2026年4月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- MA-GC-II-032
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?
いいえ
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
いいえ
米国FDA規制機器製品の研究
いいえ
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。