PD-1 Inhibitors Combined With Local Therapy at Different Timings in Oligometastatic ESCC (ESO-shanghai31)
A Phase III Randomized Controlled Study Investigating the Combination of PD-1 Inhibitors With Local Therapy Administered at Distinct Treatment Timings Among Patients With Oligometastatic Esophageal Squamous Cell Carcinoma
Although immunotherapy combined with chemotherapy has become the first-line standard regimen for advanced esophageal squamous cell carcinoma (ESCC) and improved clinical outcomes in advanced patients, the prognosis of patients with esophageal cancer remains unsatisfactory, with a 5-year overall survival rate below 20%. As an effective modality for local disease control, local radiotherapy has no established optimal sequencing schedule when combined with systemic therapy. The timing of radiotherapy intervention may directly affect treatment efficacy, treatment tolerance and quality of life of patients.
Several studies have explored the impact of radiotherapy timing in oligometastatic ESCC, yet substantial limitations persist in current evidence, resulting in a lack of unified guideline recommendations and wide heterogeneity in clinical practice. Most existing investigations are retrospective or small-sample prospective studies with high heterogeneity in study design, patient population selection and treatment regimens, yielding inconsistent conclusions that cannot support consistent clinical consensus.
To clarify the impact of radiotherapy timing on clinical efficacy in oligometastatic esophageal cancer, the investigator designed the present clinical trial. This study aims to compare the efficacy and safety of concurrent radiotherapy versus sequential radiotherapy on the basis of immunochemotherapy among patients with oligometastatic ESCC, so as to fill the evidence gap in existing research.
調査の概要
状態
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Guangmin Mao
- 電話番号：86-13732284526
- メール：melly01@256.com
研究連絡先のバックアップ
- 名前：Kuaile Zhao
- 電話番号：86-18017312534
- メール：kuaile_z@fudan.edu.cn
研究場所
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Shanghai Municipality
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Shanghai、Shanghai Municipality、中国
- 募集
- Fudan University Shanghai Cancer Center
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コンタクト：
- Guangmin Mao
- 電話番号：86-13732284526
- メール：melly01@126.com
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主任研究者：
- Kuaile Zhao, 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
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- An eastern cooperative oncology group (ECOG) score of 0-1.
- Histologically or cytologically confirmed diagnosis of esophageal squamous cell carcinoma.
- Genuine oligometastasis (without a history of polyme-tastatic disease).
- A total of four or fewer distant metastases, a maximum of three metastases in a single organ, and a maximum diameter of each metastatic lesion not exceeding 5 cm.
- Biopsy of a metastatic lesion, PET/CT scan, and PD-L1 CPS (IHC 22C3) are not required but preferred.
- No history of anti-PD-1/PD-L1 therapy. However, the following conditions are also eligible for inclusion: the use of anti-PD1/PD-L1 during induction/neoadjuvant/ concurrent therapy, or the use of anti-PD1/PD-L1 for maintenance therapy but not due to toxicity or disease progression interrupting anti-PD1/PD-L1 treatment, and the interruption has lasted for more than 3 months.
- Adequate hematological, hepatic, renal, and coagula-tion function. Baseline laboratory tests required to assess eligibility, including ANC ≥ 1.5 × 10^9/L, PLT ≥ 80 × 10^9/L, Hb ≥85 g/L, ALB ≥28 g/L, TBIL ≤ 1.5 × ULN, ALT and AST ≤ 3 × ULN, Cr ≤ 1.5 × ULN or CrCl ≥40 mL/min, FEV1 ≥ 1 L. (liver metastases ALT and AST ≤ 5 × ULN, liver or bone metastases AKP ≤ 5 × ULN).(9) Enrolled voluntarily and signed informed consent by the patient himself or his legal representative.
Exclusion Criteria:
- Pregnant or lactating women.
- Lung V20 remains over 25%.
- Confirmed diagnosis or clinical suspicion of esophageal fistula.
- Recurrence in the irradiated field.
- Active infection requiring systemic therapy.
- Active autoimmune disease requiring systemic treat-ment in the past 2 years.
- Immunodeficiency diagnosis, systemic steroid therapy, or any immunosuppressive treatment within 7 days before the first study treatment dose.
- Patients with a known history of grade 3 or higher adverse events, which are unsuitable for Anti-PD-1 therapy or adverse events that have not recovered to ≤CTCAE grade 1 (except alopecia).
- Uncontrolled pleural effusion, pericardial effusion, or pelvic ascites requiring repeated drainage.
Unable or rejection to receive Anti-PD-1 therapy or unable to comply with study requirements or follow-up schedule.(11) Inability to provide informed consent.
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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
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
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Early Local Therapy Arm
Patients assigned to this study arm will initiate local therapy prior to the administration of the first two cycles of systemic treatment (immunotherapy or chemoimmunotherapy).
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Both study arms receive chemoimmunotherapy combined with local intervention modalities, which encompass radiotherapy, surgery and ablation.
In the early local therapy arm, local intervention is initiated within 2 cycles of chemoimmunotherapy, whereas patients in the delayed local therapy arm start local intervention after completing 4 cycles of chemoimmunotherapy.
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Delayed Local Therapy Arm
Patients assigned to this study arm will initiate local therapy after completion of the first four cycles of systemic treatment (immunotherapy or chemoimmunotherapy).
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Both study arms receive chemoimmunotherapy combined with local intervention modalities, which encompass radiotherapy, surgery and ablation.
In the early local therapy arm, local intervention is initiated within 2 cycles of chemoimmunotherapy, whereas patients in the delayed local therapy arm start local intervention after completing 4 cycles of chemoimmunotherapy.
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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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progression free survival (PFS）
時間枠：3-years
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PFS is defined as the time interval between the date of the first treatment and the date of first confirmed disease progression or death from any cause.
If the patient does not have tumor progression or death at the time of data analysis, the time of the last tumor evaluation will be used as the endpoint for PFS.
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3-years
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overall survival (OS)
時間枠：3-years
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the interval between the date of first systemic treatment and the date of death from any cause, and for patients who are still alive at the time point of the final analysis, the time of their last contact will be used as the survival time.
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3-years
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協力者と研究者
スポンサー
捜査官
- スタディディレクター：Kuaile Zhao, MD、Fudan University
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
- ESO-shanghai 31
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 共有サポート情報タイプ
- STUDY_PROTOCOL
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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