A Study of HS-20093 in Patients With Pretreated Advanced or Metastatic Esophageal Squamous Cell Carcinoma (ESCC)
A Multicenter, Randomized, Open-Label, Controlled Phase III Clinical Study Evaluating the Efficacy and Safety of HS-20093- Injection Versus Investigator's Choice of Chemotherapy in Patients With Locally Advanced or Metastatic Esophageal Squamous Cell Carcinoma After Progress of First-Line Standard Therapy
調査の概要
詳細な説明
This is a multicenter, randomized, open-label, controlled phase III clinical study to evaluate the efficacy and safety of HS-20093- injection versus investigator's choice of chemotherapy in patients with locally advanced or metastatic esophageal squamous cell carcinoma after progress of first-line standard therapy.
Eligible participants will be randomly assigned in a 1:1 ratio to the experimental arm (HS-20093) or the control arm (investigator's choice of monochemotherapy, including irinotecan, paclitaxel, or docetaxel). Both experimental arm and control arm will receive a treatment cycle of 21 days until disease progression or other treatment discontinuation criteria are met; Efficacy and safety will be analyzed and evaluated in both arms following the protocol-specified follow-up procedure.
研究の種類
入学 (推定)
段階
- フェーズ 3
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 years at the time of informed consent form (ICF) signature, either sex.
- Be willing to participate in this clinical trial with understanding of study procedures, ability to provide written informed consent, and commitment to comply with all requirements specified in this clinical trial protocol.
- Patients with histologically or cytologically confirmed diagnosis of advanced recurrent or metastatic esophageal squamous cell carcinoma (ESCC), progressed after receiving first-line standard treatment.
- Presence of at least one target lesion according to RECIST v1.1.
- Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 to 1.
- Minimum life expectancy >12 weeks.
- Adequate organ function.
- Absence of the following active infectious diseases: hepatitis B, hepatitis C, human immunodeficiency virus (HIV) infection, tuberculosis, or syphilis.
- Female patients with negative serum pregnancy test result within 7 days prior to first dose administration, or documentation of no pregnancy risk.
Exclusion Criteria:
1. Prior pathological diagnosis of esophageal adenocarcinoma, esophageal adenoid cystic carcinoma, esophageal mucoepidermoid carcinoma, esophageal undifferentiated carcinoma, esophageal neuroendocrine carcinoma, or esophageal mixed carcinoma 2. Prior or ongoing treatment with any of the following:
- Prior or current treatment targeting B7-H3;
Prior or current treatment with topoisomerase I inhibitor agents, including antibody-drug conjugates with topoisomerase I inhibitor payloads, etc.; 3. Persistent adverse reactions caused by prior treatment. 4. Untreated brain metastases; uncontrolled brain metastases; presence of leptomeningeal or brainstem metastases; presence of spinal cord compression.
5. History of other primary malignancies. 6. Severe, uncontrolled, or active cardiovascular or cerebrovascular disease. 7. Severe or poorly controlled hypertension and diabetes mellitus. 8. Tumors have the risk of leading perforation/fistula, hemorrhage, or obstruction.
9. Known or suspected interstitial pneumonitis, immune-mediated pneumonitis, or radiation pneumonitis.
10. Known to have allergic reactions or contraindications to the investigational medicinal product.
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：HS-20093 for injection
|
The patient will receive treatment with HS-20093.
他の名前：
|
|
アクティブコンパレータ：Investigator's choice of monochemotherapy
Investigator should choose one of the monochemotherapy (irinotecan, paclitaxel, or docetaxel)
|
The patient will receive treatment with Irinotecan or Paclitaxel or Docetaxel
|
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 |
|---|---|---|
|
Overall survival (OS)
時間枠：Approximately 4 years after the first patient with first dose
|
Overall Survival is defined as the time from the date of randomization to the date of participant's death due to any cause
|
Approximately 4 years after the first patient with first dose
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
有害事象の発生率および重症度
時間枠：最初の投与から最終投与後90日まで
|
最初の投与から最終投与後90日まで
|
|
|
重篤な有害事象の発生率と重症度
時間枠：最初の投与から最後の投与後90日まで
|
最初の投与から最後の投与後90日まで
|
|
|
Progression-free survival (PFS) assessed by investigator
時間枠：Approximately 3 years after the first patient with first dose
|
PFS assessed by investigator per RECIST v1.1
|
Approximately 3 years after the first patient with first dose
|
|
Objective response rate (ORR)
時間枠：Approximately 2 years after the first patient with first dose
|
ORR assessed by investigator per RECIST v1.1
|
Approximately 2 years after the first patient with first dose
|
|
Disease control rate (DCR)
時間枠：Approximately 2 years after the first patient with first dose
|
DCR assessed by investigator per RECIST v1.1
|
Approximately 2 years after the first patient with first dose
|
|
Duration of response (DoR)
時間枠：Approximately 3 years after the first patient with first dose
|
DoR assessed by investigator per RECIST v1.1
|
Approximately 3 years after the first patient with first dose
|
協力者と研究者
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
追加の関連 MeSH 用語
その他の研究ID番号
- HS-20093-310
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
米国で製造され、米国から輸出された製品。
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