Induction Chemo-Immunotherapy + Radiotherapy vs Concurrent Chemoradiotherapy for Unresectable Locally Advanced Esophageal Squamous Cell Carcinoma
2026年4月26日 更新者：Second Affiliated Hospital of Zunyi Medical University
Efficacy and Safety of Induction Chemo-Immunotherapy Followed by Radiotherapy vs Concurrent Chemoradiotherapy in Unresectable Locally Advanced Esophageal Squamous Cell Carcinoma: A Randomized, Two-Arm, Phase II Study
This is a prospective, randomized, phase II clinical study in patients with unresectable stage III-IVA esophageal squamous cell carcinoma (ESCC).
Eligible patients will be randomly assigned in a 1:1 ratio to two treatment groups.
The experimental group will receive 3 cycles of induction therapy with PD-1 antibody plus chemotherapy, followed by radiotherapy, and then maintenance therapy with PD-1 antibody monotherapy.
The control group will receive concurrent chemoradiotherapy, followed by maintenance therapy with PD-1 antibody monotherapy.
The primary endpoints are the complete response (CR) rate at 3 months after radiotherapy (assessed by investigators) and the 1-year progression-free survival (PFS) rate.
Secondary endpoints include overall survival (OS), progression-free survival (PFS), duration of response, objective response rate (ORR), local-regional recurrence-free survival (LRFS), distant metastasis-free survival (DMFS), quality of life, and safety profile.
調査の概要
状態
募集
詳細な説明
This is a prospective, randomized, two-arm, phase II clinical trial investigating induction chemo-immunotherapy followed by sequential radiotherapy versus concurrent chemo-immunotherapy plus radiotherapy in patients with unresectable locally advanced esophageal squamous cell carcinoma (ESCC).
Current standard of care for unresectable locally advanced ESCC is definitive concurrent chemoradiotherapy. However, outcomes remain suboptimal, with high rates of local recurrence and distant metastasis. The addition of PD-1 inhibitors to concurrent chemoradiotherapy has shown promising activity in recent studies, but optimal sequencing and integration of immunotherapy with radiotherapy are still under investigation.
This trial is designed to evaluate whether an induction strategy with chemo-immunotherapy followed by radiotherapy can improve response rates and long-term survival compared to the standard concurrent approach. Patients will be randomized to receive either:
- Experimental arm: Three cycles of induction chemo-immunotherapy, followed by definitive thoracic radiotherapy, then maintenance immunotherapy for up to one year.
- Control arm: Concurrent chemo-immunotherapy plus definitive thoracic radiotherapy, followed by maintenance immunotherapy for up to one year.
The primary objective is to compare the efficacy of the two regimens in terms of complete response and progression-free survival. Safety, tolerability, and quality of life will also be assessed to support the risk-benefit profile of each strategy.
研究の種類
介入
入学 (推定)
92
段階
- フェーズ2
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Jian-Guo Zhou, PhD
- 電話番号：+86-851-18212154044
- メール：jsdxzl@126.com
研究場所
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Guizhou
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Zunyi、Guizhou、中国、563000
- 募集
- The Second Affiliated Hospital of Zunyi Medical University, Xinpu New District, Honghuagang District, Zunyi City, Guizhou Province
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コンタクト：
- lei zhou, Master
- 電話番号：+86-851-18212154044
- メール：jsdxzl@126.com
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
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
いいえ
説明
Inclusion Criteria:
- Histologically or cytologically confirmed unresectable stage III-IVA esophageal squamous cell carcinoma (ESCC)
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Adequate organ function (bone marrow, liver, renal, cardiac) within 2 weeks prior to randomization
- Measurable or evaluable disease per RECIST 1.1
- Willing to provide written informed consent
Exclusion Criteria:
- Previous radiotherapy to the chest or previous systemic chemotherapy for ESCC
- History of other malignancies within the last 5 years (except cured basal cell carcinoma or cervical carcinoma in situ)
- Severe comorbidities (uncontrolled hypertension, NYHA class III-IV heart failure, active infection, etc.)
- Known hypersensitivity to any study drugs (paclitaxel, cisplatin/carboplatin, PD-1 antibody)
- Pregnant or lactating women
- Participation in another clinical trial within 30 days prior to randomization
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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：4倍
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：Experimental Group: Chemo-Immunotherapy Induction + Radiotherapy + PD-1 Maintenance
Patients receive 3 cycles of PD-1 antibody plus chemotherapy induction therapy, followed by thoracic radiotherapy (50.4Gy in 28 fractions), then PD-1 antibody maintenance therapy (200mg IV q3w, up to 1 year).
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Paclitaxel 150-175 mg/m² combined with cisplatin 75 mg/m² or carboplatin AUC 5 (maximum 600 mg), administered intravenously every 3 weeks for 3 cycles, concurrent with PD-1 antibody induction therapy for unresectable stage III-IVA esophageal squamous cell carcinoma.
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アクティブコンパレータ：Control Group: Concurrent Chemoradiotherapy + PD-1 Maintenance
Patients receive weekly paclitaxel + cisplatin/carboplatin concurrent with thoracic radiotherapy (50.4Gy in 28 fractions), then PD-1 antibody maintenance therapy (200mg IV q3w, up to 1 year).
|
Paclitaxel 50 mg/m² combined with cisplatin 25 mg/m² or carboplatin AUC 5 (maximum 600 mg), administered intravenously once weekly for 5 cycles, concurrent with thoracic radiotherapy (50.4Gy in 28 fractions) for unresectable stage III-IVA esophageal squamous cell carcinoma.
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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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Complete Response (CR) Rate at 3 Months After Radiotherapy (Investigator-Assessed)
時間枠：3 months after completion of radiotherapy
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Proportion of patients achieving complete response (CR) per RECIST 1.1, assessed by investigators at 3 months after completion of radiotherapy
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3 months after completion of radiotherapy
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1-Year Progression-Free Survival (PFS) Rate
時間枠：1 year after randomization
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Proportion of patients alive and without disease progression at 1 year after randomization
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1 year after randomization
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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 (OS)
時間枠：Up to 3 years after randomization
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Time from randomization to death from any cause
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Up to 3 years after randomization
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Progression-Free Survival (PFS)
時間枠：Up to 3 years after randomization
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Time from randomization to first documented disease progression or death from any cause, whichever occurs first
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Up to 3 years after randomization
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Duration of Response (DOR)
時間枠：Up to 3 years after randomization
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Time from first documentation of objective response (CR/PR) to first documented disease progression or death
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Up to 3 years after randomization
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Objective Response Rate (ORR)
時間枠：Up to 3 years after randomization
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Proportion of patients achieving CR or partial response (PR) per RECIST 1.1
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Up to 3 years after randomization
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Local Regional Failure-Free Survival (LRFS)
時間枠：Up to 3 years after randomization
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Time from randomization to first local or regional recurrence or death
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Up to 3 years after randomization
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Distant Metastasis-Free Survival (DMFS)
時間枠：Up to 3 years after randomization
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Time from randomization to first distant metastasis or death
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Up to 3 years after randomization
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Incidence of Treatment-Emergent Adverse Events (TEAEs)
時間枠：From first study treatment to 30 days after last treatment
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Incidence and severity of TEAEs (graded per CTCAE 5.0) during treatment and follow-up
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From first study treatment to 30 days after last treatment
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EORTC QLQ-OES18 Symptom Score Change
時間枠：Baseline, 3 months, 6 months, 12 months after radiotherapy
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Change in esophageal cancer-specific symptom score as assessed by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Oesophageal 18 (EORTC QLQ-OES18) from baseline to post-treatment follow-ups.
The scale ranges from 0 to 100, with higher scores indicating more severe symptoms and worse quality of life.
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Baseline, 3 months, 6 months, 12 months after radiotherapy
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EORTC QLQ-C30 Quality of Life Score Change
時間枠：Baseline, 3 months, 6 months, 12 months after radiotherapy.
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Change in quality of life score as assessed by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) from baseline to post-treatment follow-ups.
The scale ranges from 0 to 100, with higher scores indicating better quality of life.
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Baseline, 3 months, 6 months, 12 months after radiotherapy.
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Lei Zhou, Master、The Second Affiliated Hospital of Zunyi Medical University
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2026年1月1日
一次修了 (推定)
2028年1月1日
研究の完了 (推定)
2028年6月30日
試験登録日
最初に提出
2026年3月28日
QC基準を満たした最初の提出物
2026年4月26日
最初の投稿 (実際)
2026年4月30日
学習記録の更新
投稿された最後の更新 (実際)
2026年4月30日
QC基準を満たした最後の更新が送信されました
2026年4月26日
最終確認日
2026年4月1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
- KYLL-2025-143
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