Node-Sparing Short-Course Radiotherapy (25 Gy/5 Fractions) Combined With Chemoimmunotherapy as Neoadjuvant Treatment for Locally Advanced Esophageal Squamous Cell Carcinoma:A Prospective Single-Arm, Phase II Study (NeoSCRTIC-01)
調査の概要
詳細な説明
The study is designed as a Simon optimal two-stage, single-arm phase II trial. The target sample size is 33 participants, allowing for approximately 10% attrition. In stage 1, 15 participants will be enrolled; if at least 4 achieve pathologic complete response, enrollment will proceed to stage 2. A further 15 evaluable participants will then be enrolled. The protocol considers the regimen promising if at least 15 of 30 evaluable participants achieve pathologic complete response.
Eligible participants are treatment-naive adults aged 18-75 years with PET-CT and pathologically confirmed thoracic esophageal squamous cell carcinoma, clinical stage cT1b-3N1-2M0 or cT2-3N0M0 (AJCC 9th edition), ECOG performance status 0-1, measurable disease by RECIST v1.1, and disease considered amenable to R0 resection.
Neoadjuvant treatment consists of camrelizumab 200 mg intravenously on Day 1 every 3 weeks plus nab-paclitaxel 260 mg/m² on Day 1 and carboplatin AUC 5 on Day 1 for three cycles. Short-course radiotherapy (25 Gy in 5 fractions over 5 days) is delivered after the first cycle, targeting only the primary tumor and positive lymph nodes and sparing elective lymphatic drainage regions. Tumor imaging is performed after the second cycle and before surgery. McKeown esophagectomy is planned 4-6 weeks after completion of neoadjuvant therapy when hematologic and organ function have recovered. Postoperative survival follow-up is planned every 3 months for 3 years.
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:Hongying Liao MD, Professor / Chief Physician, MD and PhD
- 電話番号:+86-020-35919121
- メール:liaohy2@mail.sysu.edu.cn
研究場所
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Guangdong
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Guanzhou、Guangdong、中国、510655
- 募集
- The Sixth Affiliated Hospital, Sun Yat-sen University
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コンタクト:
- Hongying Liao MD, Professor / Chief Physician, MD and PhD
- 電話番号:+86-020-35919121
- メール:liaohy2@mail.sysu.edu.cn
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コンタクト:
- Jiayan Wu MD, MD and PhD
- 電話番号:+86-020-35919121
- メール:wujy526@mail.sysu.edu.cn
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主任研究者:
- Hongying Liao, MD
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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:
- Written informed consent before enrollment.
- Age 18 to 75 years, any sex.
- Treatment-naive esophageal squamous cell carcinoma confirmed by pathology and PET-CT.
- Clinical stage cT1b-3N1-2M0 or cT2-3N0M0 (stage II/III according to the AJCC 9th edition).
- Disease assessed as amenable to R0 surgical resection before treatment.
- At least one measurable lesion according to RECIST v1.1.
- ECOG performance status 0-1.
- Adequate organ function: absolute neutrophil count ≥1,500/mm³; platelets ≥100,000/mm³; hemoglobin ≥9 g/dL; serum creatinine ≤1.5 mg/dL and/or creatinine clearance ≥60 mL/min; bilirubin ≤1.5×ULN; AST and ALT ≤1.5×ULN; no blood components or hematopoietic growth factors within 14 days.
- For women of childbearing potential: medically accepted contraception during treatment and for 3 months afterward; negative serum or urine HCG within 7 days before enrollment; not breastfeeding.
- For men who are not surgically sterile: agreement to use medically accepted contraception with their partner during treatment and for 3 months afterward.
- Willingness to participate and comply with safety and survival follow-up.
Exclusion Criteria:
- Prior radiotherapy, chemotherapy, prolonged/high-dose corticosteroid therapy, surgery, or molecular targeted therapy.
- Previous or concurrent other malignancy.
- Prior PD-1/PD-L1 therapy; known allergy to macromolecular protein preparations or any component of PD-1 therapy.
- Active autoimmune disease or relevant autoimmune disease history as specified in the protocol.
- Immunosuppressive agents for immunosuppression within 2 weeks before enrollment.
- Symptomatic pleural or peritoneal effusion requiring therapeutic puncture or drainage.
- Poorly controlled clinically significant cardiac disease as specified in the protocol.
- Abnormal coagulation with bleeding tendency or thrombolytic/anticoagulant therapy.
- Recent gastrointestinal conditions associated with bleeding or perforation risk.
- Severe bleeding within 3 months, hemoptysis within 4 weeks, or thromboembolic event within 12 months according to protocol thresholds.
- Active infection or unexplained fever >38.5°C during screening or before first dose.
- Abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 4 weeks before study treatment.
- History/current pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonitis, or severe pulmonary dysfunction.
- Congenital/acquired immunodeficiency including HIV infection, or active hepatitis outside protocol-defined limits.
- Participation in another clinical study or completion of a previous clinical study within 1 month; anticipated need for other systemic anticancer therapy.
- Live vaccine within 4 weeks before study treatment or anticipated during the study.
- Known history of psychotropic drug abuse, alcohol abuse, or illicit drug abuse.
- Unable or unwilling to bear self-paid portions of study-related examinations or treatment.
- Any other condition considered by the investigator to compromise participant safety, study completion, or data/sample collection.
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 |
|---|---|
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実験的:Neoadjuvant SCRT + Camrelizumab + Nab-Paclitaxel/Carboplatin
Participants receive three 3-week cycles of camrelizumab plus nab-paclitaxel and carboplatin.
Lymphatic-drainage-sparing short-course radiotherapy (25 Gy in 5 fractions over 5 days) is delivered after the first cycle.
McKeown esophagectomy is planned 4-6 weeks after completion of neoadjuvant treatment.
|
Participants receive three 3-week cycles of camrelizumab plus nab-paclitaxel and carboplatin. Lymphatic-drainage-sparing short-course radiotherapy (25 Gy in 5 fractions over 5 days) is delivered after the first cycle. McKeown esophagectomy is planned 4-6 weeks after completion of neoadjuvant treatment. Drug: Camrelizumab Camrelizumab 200 mg intravenously on Day 1 of each 3-week cycle for 3 cycles. Drug: Nab-paclitaxel Nab-paclitaxel 260 mg/m² intravenously on Day 1 of each 3-week cycle for 3 cycles. Drug: Carboplatin Carboplatin AUC 5 intravenously on Day 1 of each 3-week cycle for 3 cycles. Radiation: Short-course radiotherapy 25 Gy in 5 fractions over 5 days, delivered to the primary tumor and radiographically positive lymph nodes while elective lymphatic drainage regions are spared. Procedure: McKeown esophagectomy McKeown esophagectomy with thoracoabdominal two-field lymph node dissection, planned 4-6 weeks after completion of neoadjuvant therapy (maximum extension of 2 additional |
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 |
|---|---|---|
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Pathologic Complete Response (pCR) Rate
時間枠:At definitive surgery, approximately 4-8 weeks after completion of neoadjuvant therapy.
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Percentage of participants undergoing definitive surgery who have no residual viable tumor in the resected primary tumor and regional lymph nodes, defined in the protocol as ypT0N0.
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At definitive surgery, approximately 4-8 weeks after completion of neoadjuvant therapy.
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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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Major Pathologic Response (MPR) Rate
時間枠:At definitive surgery, approximately 4-8 weeks after completion of neoadjuvant therapy.
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Major pathologic response (MPR) is defined as ≤10% residual viable tumor cells in the primary esophageal tumor resection specimen, regardless of lymph node status, as pre-specified in study protocol.
The percentage of participants achieving this protocol-defined MPR criterion in post-neoadjuvant surgical resection specimen will be calculated.
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At definitive surgery, approximately 4-8 weeks after completion of neoadjuvant therapy.
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Objective Response Rate (ORR)
時間枠:From baseline to the preoperative tumor assessment, approximately 9-15 weeks after initiation of neoadjuvant therapy.
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Percentage of participants with complete response or partial response according to RECIST v1.1 based on protocol-specified imaging assessments.
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From baseline to the preoperative tumor assessment, approximately 9-15 weeks after initiation of neoadjuvant therapy.
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R0 Resection Rate
時間枠:Upon completion of final postoperative pathological assessment, expected within 7 days post-operatively
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Percentage of participants undergoing esophagectomy with microscopically negative resection margins.
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Upon completion of final postoperative pathological assessment, expected within 7 days post-operatively
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Disease-Free Survival (DFS) Rate
時間枠:1 year and 3 years after surgery.
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Disease-free survival rate at 1 and 3 years.
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1 year and 3 years after surgery.
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Overall Survival (OS) Rate
時間枠:1 year and 3 years after surgery.
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Overall survival rate at the specified time points.
Survival will be estimated using the Kaplan-Meier method.
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1 year and 3 years after surgery.
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協力者と研究者
出版物と役立つリンク
一般刊行物
- van Hagen P, Hulshof MC, van Lanschot JJ, Steyerberg EW, van Berge Henegouwen MI, Wijnhoven BP, Richel DJ, Nieuwenhuijzen GA, Hospers GA, Bonenkamp JJ, Cuesta MA, Blaisse RJ, Busch OR, ten Kate FJ, Creemers GJ, Punt CJ, Plukker JT, Verheul HM, Spillenaar Bilgen EJ, van Dekken H, van der Sangen MJ, Rozema T, Biermann K, Beukema JC, Piet AH, van Rij CM, Reinders JG, Tilanus HW, van der Gaast A; CROSS Group. Preoperative chemoradiotherapy for esophageal or junctional cancer. N Engl J Med. 2012 May 31;366(22):2074-84. doi: 10.1056/NEJMoa1112088.
- Pennathur A, Gibson MK, Jobe BA, Luketich JD. Oesophageal carcinoma. Lancet. 2013 Feb 2;381(9864):400-12. doi: 10.1016/S0140-6736(12)60643-6.
便利なリンク
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
- 2026ZSLYEC-647
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
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