Cette page a été traduite automatiquement et l'exactitude de la traduction n'est pas garantie. Veuillez vous référer au version anglaise pour un texte source.

Induction Chemo-Immunotherapy + Radiotherapy vs Concurrent Chemoradiotherapy for Unresectable Locally Advanced Esophageal Squamous Cell Carcinoma

26 avril 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

92

Phase

  • Phase 2

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

  • Nom: Jian-Guo Zhou, PhD
  • Numéro de téléphone: +86-851-18212154044
  • E-mail: jsdxzl@126.com

Lieux d'étude

  • Chine
    • Guizhou
      • Zunyi, Guizhou, Chine, 563000
        • Recrutement
        • The Second Affiliated Hospital of Zunyi Medical University, Xinpu New District, Honghuagang District, Zunyi City, Guizhou Province
        • Contact:
          • lei zhou, Master
          • Numéro de téléphone: +86-851-18212154044
          • E-mail: jsdxzl@126.com

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Quadruple

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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).
Médicament: Paclitaxel plus Cisplatin or Carboplatin (Induction Chemotherapy)
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.
Comparateur actif: 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).
Médicament: Weekly Paclitaxel plus Cisplatin or Carboplatin (Concurrent Chemotherapy)
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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Complete Response (CR) Rate at 3 Months After Radiotherapy (Investigator-Assessed)
Délai: 3 months after completion of radiotherapy
Proportion of patients achieving complete response (CR) per RECIST 1.1, assessed by investigators at 3 months after completion of radiotherapy
3 months after completion of radiotherapy
1-Year Progression-Free Survival (PFS) Rate
Délai: 1 year after randomization
Proportion of patients alive and without disease progression at 1 year after randomization
1 year after randomization

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Overall Survival (OS)
Délai: Up to 3 years after randomization
Time from randomization to death from any cause
Up to 3 years after randomization
Progression-Free Survival (PFS)
Délai: Up to 3 years after randomization
Time from randomization to first documented disease progression or death from any cause, whichever occurs first
Up to 3 years after randomization
Duration of Response (DOR)
Délai: Up to 3 years after randomization
Time from first documentation of objective response (CR/PR) to first documented disease progression or death
Up to 3 years after randomization
Objective Response Rate (ORR)
Délai: Up to 3 years after randomization
Proportion of patients achieving CR or partial response (PR) per RECIST 1.1
Up to 3 years after randomization
Local Regional Failure-Free Survival (LRFS)
Délai: Up to 3 years after randomization
Time from randomization to first local or regional recurrence or death
Up to 3 years after randomization
Distant Metastasis-Free Survival (DMFS)
Délai: Up to 3 years after randomization
Time from randomization to first distant metastasis or death
Up to 3 years after randomization
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Délai: From first study treatment to 30 days after last treatment
Incidence and severity of TEAEs (graded per CTCAE 5.0) during treatment and follow-up
From first study treatment to 30 days after last treatment
EORTC QLQ-OES18 Symptom Score Change
Délai: Baseline, 3 months, 6 months, 12 months after radiotherapy
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.
Baseline, 3 months, 6 months, 12 months after radiotherapy
EORTC QLQ-C30 Quality of Life Score Change
Délai: Baseline, 3 months, 6 months, 12 months after radiotherapy.
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.
Baseline, 3 months, 6 months, 12 months after radiotherapy.

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Second Affiliated Hospital of Zunyi Medical University

Les enquêteurs

  • Chercheur principal: Lei Zhou, Master, The Second Affiliated Hospital of Zunyi Medical University

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 janvier 2026

Achèvement primaire (Estimé)

1 janvier 2028

Achèvement de l'étude (Estimé)

30 juin 2028

Dates d'inscription aux études

Première soumission

28 mars 2026

Première soumission répondant aux critères de contrôle qualité

26 avril 2026

Première publication (Réel)

30 avril 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

30 avril 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

26 avril 2026

Dernière vérification

1 avril 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • KYLL-2025-143

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

S'abonner