Adebrelimab Combined With Neoadjuvant Chemotherapy in Borderline Resectable Locally Advanced Esophageal Squamous Cell Carcinoma (NEOCRTEC2501)
Phase II Trial of Adebrelimab Combined With Nab-paclitaxel and Carboplatin for Neoadjuvant Therapy in Patients With Borderline Resectable Locally Advanced Esophageal Squamous Cell Carcinoma
調査の概要
詳細な説明
Study participants shall complete the informed consent process and undergo multidisciplinary team (MDT) review for esophageal cancer. Patients confirmed as having borderline resectable disease and meeting all inclusion/exclusion criteria will be enrolled and receive treatment with adebrelimab plus albumin-bound paclitaxel and carboplatin.
The treatment regimen is administered in 3-week cycles. Efficacy evaluation will be performed after 2 cycles:
If the disease converts to resectable status, radical surgery will be conducted.
If the disease is assessed as unresectable (progressive disease [PD] / stable disease [SD]), patients will receive definitive chemoradiotherapy or first-line treatment for advanced disease.
If partial tumor regression is observed but the tumor remains unresectable, a third treatment cycle will be administered, followed by another efficacy evaluation. If the disease becomes resectable after the third cycle, radical surgery will be performed; if still unresectable (PD/SD), definitive chemoradiotherapy or first-line treatment for advanced disease will be given.
For patients who achieve R0 resection, the investigator will determine the necessity of adjuvant therapy based on individual patient conditions. Patients with R1/R2 resection will receive concurrent chemoradiotherapy. If the MDT determines that radical resection is not feasible, patients will receive definitive concurrent chemoradiotherapy.
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:Hong Yang, MD, PhD
- 電話番号:86-13560405144
- メール:yanghong@sysucc.org.cn
研究連絡先のバックアップ
- 名前:Chief physician
- 電話番号:86-13560405144
研究場所
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Guangdong
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Guangzhou、Guangdong、中国、510000
- 募集
- No. 651 Dongfeng East Road, Guangzhou
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コンタクト:
- Hong Yang Chief Physician
- 電話番号:86-13560405144
- メール:yanghong@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:1.Voluntarily participate in the study and sign the written informed consent form.
2.Aged between 18 and 75 years old. 3.Histologically confirmed thoracic esophageal squamous cell carcinoma without distant metastasis. Patients are defined as borderline resectable after enhanced computed tomography (CT), and/or endoscopic ultrasonography (EUS), endobronchial ultrasonography (EBUS) and multidisciplinary team (MDT) discussion.
4.No prior chemotherapy or radiotherapy. 5.Estimated overall survival of no less than 3 months. 6.Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1.
7.Hematological parameters (tested within 7 days): Hemoglobin (Hb) ≥ 90 g/L; Neutrophil count (NE) ≥ 1.5×10⁹/L; Platelet count (PLT) ≥ 100×10⁹/L.
8.Hepatic and renal function (tested within 7 days): Total bilirubin ≤ 1.5 × upper limit of normal (ULN); Creatinine ≤ 1.5 × ULN; Aspartate transaminase (AST)/Alanine transaminase (ALT) ≤ 2.5 × ULN; Alkaline phosphatase (ALP) ≤ 5.0 × ULN.
9.Absence of severe complications, including active massive gastrointestinal bleeding, perforation, jaundice, intestinal obstruction, and non-neoplastic fever above 38°C.
10.Fertile patients must adopt effective contraceptive measures throughout the study period.
11.Good treatment compliance, and able to complete follow-up assessments for efficacy and adverse events as required by the protocol.
Exclusion Criteria:
- Patients with cervical esophageal squamous cell carcinoma.
- Patients with distant metastasis.
- Patients with nearly complete esophageal obstruction confirmed by endoscopy who require interventional therapy for decompression.
- Patients with prior placement of esophageal or tracheal stents.
- Patients with high risk of bleeding or perforation due to obvious tumor invasion into adjacent vital organs (major arteries or trachea), or patients with existing fistula formation.
- Patients with other concurrent primary malignancies (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix).
- Use of immunosuppressive drugs within 1 week prior to enrollment. This exclusion does not apply to intranasal, inhaled or other topical glucocorticoids, systemic glucocorticoids at physiological doses (i.e., prednisone ≤ 10 mg/day or equivalent), or glucocorticoids administered for contrast medium allergy prophylaxis.
- Active autoimmune diseases requiring symptomatic treatment, or a medical history of such diseases within the past 2 years.
- Known history of primary immunodeficiency.
- Confirmed active tuberculosis.
- History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
- Interstitial lung disease requiring corticosteroid therapy. 13Known allergy to any monoclonal antibody, chemotherapeutic agents (taxanes, carboplatin), or their excipients.
14.Severe cardiac diseases, including documented congestive heart failure, uncontrolled high-risk arrhythmia, medically treated angina pectoris, clinically significant valvular heart disease, history of severe myocardial infarction, and refractory hypertension.
15.Chronic diarrhea (≥4 watery stools per day) or renal insufficiency. 16.Active infection or active communicable diseases. 17.Neurological or psychiatric disorders impairing cognitive function. 18.Pregnant or breastfeeding women. 19.Other acute or chronic diseases, psychiatric disorders or abnormal laboratory findings that, in the investigator's judgment, may increase risks related to study participation or study drug administration, or interfere with the interpretation of study results.
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: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:Experimental
Adebrelimab plus nab-paclitaxel, carboplatin
|
Study participants shall complete the informed consent process and undergo multidisciplinary team (MDT) review for esophageal cancer.
Patients confirmed as having borderline resectable disease and meeting all inclusion/exclusion criteria will be enrolled and receive treatment with adebrelimab plus albumin-bound paclitaxel and carboplatin.The treatment regimen is administered in 3-week cycles.
Efficacy evaluation will be performed after 2 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 |
|---|---|---|
|
R0 resection rate
時間枠:From patient enrollment to two weeks post-surgery
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The proportion of patients with tumor margins showing no residual cancer cells under the microscope after surgical resection.
That is, the proportion of patients in PPS achieving R0 resection.
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From patient enrollment to two weeks post-surgery
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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 |
|---|---|---|
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Overall survival
時間枠:up to 5 years post-surgery
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OS is the time interval from the start of treatment to death due to any reason or loss of follow-up
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up to 5 years post-surgery
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Progression free survival
時間枠:up to 5 years post-surgery
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Disease free survival (DFS) refers to the time from the start of treatment until disease recurrence or death from any cause, whichever occurs first.
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up to 5 years post-surgery
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Pathologic complete response rate
時間枠:From patient enrollment to two weeks post-surgery
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From patient enrollment to two weeks post-surgery
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Incidence of perioperative complications
時間枠:from the first drug administration to within 30 days after the last intended treatment
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from the first drug administration to within 30 days after the last intended treatment
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Tumor Regression Grade
時間枠:From patient enrollment to two weeks post-surgery
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From patient enrollment to two weeks post-surgery
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協力者と研究者
スポンサー
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
- SL-B2025-491-05
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?
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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