Induction Chemo-Immunotherapy + Radiotherapy vs Concurrent Chemoradiotherapy for Unresectable Locally Advanced Esophageal Squamous Cell Carcinoma
26 april 2026 uppdaterad 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.
Studieöversikt
Status
Rekrytering
Betingelser
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Beräknad)
92
Fas
- Fas 2
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Jian-Guo Zhou, PhD
- Telefonnummer: +86-851-18212154044
- E-post: jsdxzl@126.com
Studieorter
-
-
Guizhou
-
Zunyi, Guizhou, Kina, 563000
- Rekrytering
- The Second Affiliated Hospital of Zunyi Medical University, Xinpu New District, Honghuagang District, Zunyi City, Guizhou Province
-
Kontakt:
- lei zhou, Master
- Telefonnummer: +86-851-18212154044
- E-post: jsdxzl@126.com
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Fyrdubbla
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: 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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Complete Response (CR) Rate at 3 Months After Radiotherapy (Investigator-Assessed)
Tidsram: 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
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3 months after completion of radiotherapy
|
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1-Year Progression-Free Survival (PFS) Rate
Tidsram: 1 year after randomization
|
Proportion of patients alive and without disease progression at 1 year after randomization
|
1 year after randomization
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Overall Survival (OS)
Tidsram: Up to 3 years after randomization
|
Time from randomization to death from any cause
|
Up to 3 years after randomization
|
|
Progression-Free Survival (PFS)
Tidsram: 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)
Tidsram: 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
|
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Objective Response Rate (ORR)
Tidsram: Up to 3 years after randomization
|
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)
Tidsram: Up to 3 years after randomization
|
Time from randomization to first local or regional recurrence or death
|
Up to 3 years after randomization
|
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Distant Metastasis-Free Survival (DMFS)
Tidsram: Up to 3 years after randomization
|
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)
Tidsram: 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
|
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EORTC QLQ-OES18 Symptom Score Change
Tidsram: 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.
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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
Tidsram: 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.
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Baseline, 3 months, 6 months, 12 months after radiotherapy.
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Huvudutredare: Lei Zhou, Master, The Second Affiliated Hospital of Zunyi Medical University
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 januari 2026
Primärt slutförande (Beräknad)
1 januari 2028
Avslutad studie (Beräknad)
30 juni 2028
Studieregistreringsdatum
Först inskickad
28 mars 2026
Först inskickad som uppfyllde QC-kriterierna
26 april 2026
Första postat (Faktisk)
30 april 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
30 april 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
26 april 2026
Senast verifierad
1 april 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Neoplasmer efter plats
- Neoplasmer
- Neoplasmer efter histologisk typ
- Gastrointestinala neoplasmer
- Neoplasmer i matsmältningssystemet
- Matsmältningssystemets sjukdomar
- Gastrointestinala sjukdomar
- Neoplasmer i huvud och hals
- Neoplasmer, körtel och epitel
- Esofagussjukdomar
- Carcinom
- Neoplasmer, skivepitelceller
- Karcinom, skivepitel
- Esofagusneoplasmer
- Esofagus skivepitelcancer
- Organiska kemikalier
- Terapeutik
- Narkotikabehandling
- Kolväten
- Cykloparaffiner
- Kolväten, alicyklisk
- Kolväten, cykliska
- Terpener
- Oorganiska kemikalier
- Klorföreningar
- Kväveföreningar
- Koordinationskomplex
- Taxoids
- Cyklodekaner
- Gentare
- Platinaföreningar
- Remission induktion
- Karboplatin
- Paklitaxel
- Cisplatin
- Induktionskemoterapi
Andra studie-ID-nummer
- KYLL-2025-143
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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