RecruitingPhase 1Phase 2NCT06173986

Immunotherapy in Combination With Chemoradiotherapy in Unresectable Locally Advanced Esophageal Cancer

A Phase I/II Multicenter Study Evaluating the Efficacy and Safety of Induction Immunochemotherapy Followed by Concurrent Immuno-Chemoradiotherapy in Unresectable Locally Advanced Esophageal Squamous Cell Cancer(SCR-ESCC-02)


Sponsor

Shanghai Chest Hospital

Enrollment

50 participants

Start Date

Jan 10, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

SCR-ESCC-02 is a multicenter, phase I/II clinical study to investigate the safety and efficacy of induction immunochemotherapy followed by concurrent chemoradiotherapy with anti-PD-1 therapy in patients diagnosed with locally advanced, unresectable esophageal cancer.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether adding immunotherapy (a drug that helps the immune system fight cancer) to standard chemoradiation treatment — chemotherapy plus radiation given together — improves outcomes for people with locally advanced esophageal cancer that cannot be surgically removed. **You may be eligible if...** - You are between 18 and 75 years old with locally advanced esophageal cancer that cannot be surgically removed (or you have chosen not to have surgery) - You have not had any prior cancer treatment (no chemotherapy, radiation, immunotherapy, or surgery for esophageal cancer) - You have adequate blood counts, lung, heart, kidney, and liver function - You have an ECOG performance status of 0-1 (able to carry out normal daily activities) **You may NOT be eligible if...** - You have had another cancer in the past 5 years - Your doctor believes you are at high risk of esophageal bleeding, fistula (abnormal hole), or perforation - You have autoimmune disease or are on immune-suppressing medications Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPD-1inhibitor

PD-1 inhibitor, Q3W, until disease progression or unacceptable toxicity or treatment reaches 1 year

DRUGnab-paclitaxel + cisplatin

Induction phase: nab-paclitaxel + cisplatin, Q3W × 2 cycles; Concurrent ICRT phase: nab-paclitaxel + cisplatin, QW × 5 cycles

RADIATIONRadiotherapy

Primary tumor and metastatic lymph nodes, DT:45-50Gy/25fx, starting within 4 weeks following the completion of the last induction immunochemotherapy cycle


Locations(1)

Shanghai Chest Hospital

Shanghai, China

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NCT06173986


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