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治験 NCT07493993（対象：食道扁平上皮癌 (ESCC)）は募集準備中です。詳細は治験レーダーのタイル表示と AI 発見ツールで確認するか、ここで質問してください。 | ||
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天津医科大学Clinical Study on the Efficacy and Safety of Iparomlimab and Tuvonralimab Injection Combined With Nab-Paclitaxel in Neoadjuvant Therapy for Locally Advanced Resectable Esophageal Squamous Cell Carcinoma 第II相・フェーズ2 26
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治験番号 NCT07493993 は 治療 の研究で、食道扁平上皮癌 (ESCC) に関するものです。この 第II相・フェーズ2 介入研究 臨床試験 は現在 募集準備中 で、2026年6月1日 に開始予定です。26 名の参加者 の募集が計画されています。この試験は 天津医科大学 によって主導され、2030年12月31日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2026年3月27日 です。
概要
Major objectives to evaluate the efficacy and safety of Iparomlimab and Tuvonralimab Injection (QL1706,an Anti-PD-1/CTLA-4 Combined Antibody) combined with Nab-Paclitaxel in neoadjuvant therapy for patients with locally advanced resectable esophageal squamous cell carcinoma.
詳細説明
This clinical study aims to evaluate the efficacy and safety of Iparomlimab and Tuvonralimab Injection (QL1706,an Anti-PD-1/CTLA-4 Combined Antibody) combined with Nab-Paclitaxel in neoadjuvant therapy for patients with locally advanced resectable esophageal squamous cell carcinoma.This study consists of three phases: screening, treatment, and follow-up.Efficacy evaluation and safety monitoring should be performed th...もっと見る
公式タイトル
Clinical Study on the Efficacy and Safety of Iparomlimab and Tuvonralimab Injection Combined With Nab-Paclitaxel in Neoadjuvant Therapy for Locally Advanced Resectable Esophageal Squamous Cell Carcinoma
疾患名
食道扁平上皮癌 (ESCC)その他の研究識別子
- E20260292
NCT番号
開始日
2026-06-01
最終更新日
2026-03-27
終了予定日
2030-12-31
目標参加者数
26
試験の種類
介入研究
治験の相・段階
第II相・フェーズ2
状況
募集準備中
キーワード
Iparomlimab and Tuvonralimab Injection
Nab-Paclitaxel
neoadjuvant therapy
ESCC
Nab-Paclitaxel
neoadjuvant therapy
ESCC
主目的
治療
割付方法
該当なし
介入モデル
単一群割当
盲検化
なし（非盲検）
群（アーム）／介入
| 参加グループ/群 | 介入/治療法 |
|---|---|
実験的lparomlimab and Tuvonralimab Injection in Combination with Nab-Paclitaxel lparomlimab and Tuvonralimab Injection in Combination with Nab-Paclitaxel | lparomlimab and Tuvonralimab Injection in Combination with Nab-Paclitaxel Iparomlimab and Tuvonralimab Injection: 5 mg/kg, q3w; Nab-Paclitaxel: 125 mg/m² on d1 and d8, q3w; Neoadjuvant therapy is administered for 4 cycles. The appropriate surgical timing will be determined by the physician based on the patient's condition, and surgery is scheduled for 4-6 weeks after the completion of neoadjuvant therapy. |
主要評価項目
副次評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Pathologic complete response rate (pCR) | refers to the absence of viable tumor cells in both the primary tumor bed and the regional lymph nodes in the surgically resected specimens. | up to 6 month |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Major Pathologic Response rate (MPR) | up to 12 month | |
R0 Resection rate | up to 12 month | |
Event-Free Survival (EFS) | up to 12 month | |
Disease-Free Survival (DFS) | up to 12 month | |
Overall survival | Os was defined as the time from the first dose of study drug to death due to anycause. | up to 36 month |
Adverse Events | An AE was defined as any untoward medical occurrence in a pharmaceutical productwhich does not necessarily have to have a causal relationship with this treatment. | up to 36 month |
参加アシスタント
適格基準
対象年齢
成人, 高齢者
試験の最低年齢
18 Years
対象性別
全て
- Voluntarily understand and sign the informed consent form for this study.
- Age ≥ 18 years, male or female.
- Histologically or cytologically confirmed thoracic ESCC (Stage T1-2N1-2M0 or T3N0-2M0, according to the AJCC 8th edition).
- ECOG performance status of 0-2.
- No prior treatment for esophageal squamous cell carcinoma.
- Life expectancy ≥ 3 months.
- Adequate function of major organs within 7 days before the first treatment (use of any blood components or cell growth factors within 14 days before enrollment is not permitted):Hemoglobin ≥ 90 g/L; White blood cell count ≥ 3.5 × 10^9/L; Absolute neutrophil count ≥ 1.5 × 10^9/L; Platelets ≥ 80 × 10^9/L; AST and ALT ≤ 2.5 × ULN; Total bilirubin (TBIL) ≤ 1.5 × ULN; Blood urea nitrogen (BUN) and creatinine (Cr) ≤ 1.5 × ULN (and creatinine clearance (CCr) ≥ 50 mL/min); Left ventricular ejection fraction (LVEF) ≥ 50%.
- Fertile patients must agree to use reliable contraceptive methods with their partner during the trial and for at least 180 days after the last dose.
- Inability to comply with the study protocol or study procedures.
- Presence of supraclavicular lymph node metastasis.
- Obvious tumor invasion of organs adjacent to the esophageal lesion.
- Evidence of esophagomediastinal or tracheoesophageal fistula found on imaging within 4 weeks before enrollment.
- Allergy or known hypersensitivity to the study drugs or their excipients.
- Anticipated need for systemic corticosteroids or other immunosuppressive therapy during the study treatment period.
- Active autoimmune disease requiring systemic treatment, or a history of autoimmune disease.
- Positive HIV test; positive hepatitis B surface antigen with HBV-DNA > upper limit of normal; active hepatitis C virus (HCV) infection.
- History of esophageal or gastric variceal bleeding due to portal hypertension within 6 months before the first study drug administration; known severe varices on endoscopy within 3 months before the first study drug administration.
- Current interstitial pneumonia or interstitial lung disease, or a history of interstitial pneumonia or interstitial lung disease requiring steroid therapy, or other pulmonary fibrosis, organizing pneumonia that might interfere with the assessment and management of immune-related pulmonary toxicity.
- Evidence of a significant bleeding tendency or other major coagulation disorders.
- Severe cardiovascular or cerebrovascular disease.
- Other malignancies within 5 years before enrollment, except for radically resected basal cell or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix.
- History of allogeneic bone marrow transplantation or organ transplantation.
- Patients considered by the investigator to be unsuitable for participation in this study.
天津医科大学378 件のアクティブな治験を探索試験中央連絡先
連絡先: Zhansheng Jiang, Doctor, 13512035574, [email protected]
連絡先: Chang Liu
1 1カ国の場所
Tianjin Municipality
Tianjin Medical University Cancer Institute and Hospital, Tianjin, Tianjin Municipality, 300000, China
Zhansheng Jiang, 連絡先, 13512035574, [email protected]