Induction Chemo-Immunotherapy + Radiotherapy vs Concurrent Chemoradiotherapy for Unresectable Locally Advanced Esophageal Squamous Cell Carcinoma
26. april 2026 oppdatert av: 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.
Studieoversikt
Status
Rekruttering
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Antatt)
92
Fase
- Fase 2
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Jian-Guo Zhou, PhD
- Telefonnummer: +86-851-18212154044
- E-post: jsdxzl@126.com
Studiesteder
-
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Guizhou
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Zunyi, Guizhou, Kina, 563000
- Rekruttering
- The Second Affiliated Hospital of Zunyi Medical University, Xinpu New District, Honghuagang District, Zunyi City, Guizhou Province
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Ta kontakt med:
- lei zhou, Master
- Telefonnummer: +86-851-18212154044
- E-post: jsdxzl@126.com
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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).
|
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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Aktiv komparator: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Complete Response (CR) Rate at 3 Months After Radiotherapy (Investigator-Assessed)
Tidsramme: 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
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Overall Survival (OS)
Tidsramme: Up to 3 years after randomization
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Time from randomization to death from any cause
|
Up to 3 years after randomization
|
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Progression-Free Survival (PFS)
Tidsramme: 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
|
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Duration of Response (DOR)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: Up to 3 years after randomization
|
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)
Tidsramme: Up to 3 years after randomization
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Time from randomization to first distant metastasis or death
|
Up to 3 years after randomization
|
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Incidence of Treatment-Emergent Adverse Events (TEAEs)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: Lei Zhou, Master, The Second Affiliated Hospital of Zunyi Medical University
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. januar 2026
Primær fullføring (Antatt)
1. januar 2028
Studiet fullført (Antatt)
30. juni 2028
Datoer for studieregistrering
Først innsendt
28. mars 2026
Først innsendt som oppfylte QC-kriteriene
26. april 2026
Først lagt ut (Faktiske)
30. april 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
30. april 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
26. april 2026
Sist bekreftet
1. april 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Neoplasmer etter nettsted
- Neoplasmer
- Neoplasmer etter histologisk type
- Gastrointestinale neoplasmer
- Neoplasmer i fordøyelsessystemet
- Sykdommer i fordøyelsessystemet
- Gastrointestinale sykdommer
- Neoplasmer i hode og nakke
- Neoplasmer, kjertel og epitel
- Esophageal sykdommer
- Karsinom
- Neoplasmer, plateepitelceller
- Karsinom, plateepitel
- Neoplasmer i spiserøret
- Esophageal plateepitelkarsinom
- Organiske kjemikalier
- Terapeutikk
- Medikamentell terapi
- Hydrokarboner
- Cycloparaffins
- Hydrokarboner, alicyklisk
- Hydrokarboner, syklisk
- Terpener
- Uorganiske kjemikalier
- Klorforbindelser
- Nitrogenforbindelser
- Koordinasjonskomplekser
- Taxoider
- Cyclodecanes
- Diterpenes
- Platinumforbindelser
- Remisjonsinduksjon
- Karboplatin
- Paclitaxel
- Cisplatin
- Induksjon cellegift
Andre studie-ID-numre
- KYLL-2025-143
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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