Combining immunotherapy with chemoradiotherapy for 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)

This study is testing a new treatment that combines immunotherapy with chemotherapy and radiation to see if it helps people with advanced esophageal cancer live longer and complete their treatment better.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Shanghai Chest Hospital (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Shanghai)
• Trial ID: NCT06173986 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the safety and efficacy of a treatment regimen that includes induction immunochemotherapy followed by concurrent chemoradiotherapy using an anti-PD-1 therapy for patients with unresectable locally advanced esophageal cancer. The study aims to determine how well this combination can improve progression-free survival and treatment completion rates. By integrating immunotherapy into the treatment plan, the trial seeks to enhance tumor regression and optimize the effectiveness of subsequent radiotherapy.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with unresectable locally advanced esophageal squamous cell carcinoma and a good performance status.

Not a fit: Patients with a history of other malignancies, those with high risks of gastrointestinal complications, or those who have received prior anti-tumor treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve treatment outcomes for patients with advanced esophageal cancer who currently have limited options.

How similar studies have performed: Other studies have shown promising results with immunotherapy in advanced esophageal cancer, but the specific combination approach in this trial is novel.

Eligibility criteria

Inclusion Criteria:

1. Age between 18 and 75 years.
2. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
3. Clinical stage meeting the criteria of T1N+M0 or T2-4aN0-3M0 based on the 8th UICC-TNM classification.
4. Ineligibility for surgical resections due to patients' unwillingness for surgery, technically unresectable disease, or being medically unfit for surgery.
5. No prior anti-tumor treatment, including surgery, radiotherapy, chemotherapy, immunotherapy, or targeted therapy.
6. Adequate hematological, pulmonary, cardiac, hepatic, renal, and thyroid function.
7. Willingness to use contraception with an adequate method throughout the study.
8. Documented informed consent.

Exclusion Criteria:

1. History of malignant disease within the 5 years preceding enrollment or presence of other malignant tumors or non-squamous cell carcinoma components.
2. High risk of gastrointestinal bleeding, esophageal fistula, or esophageal perforation as determined by the investigators.
3. Weight loss exceeding 20% within the 90 days prior to the first day of drug administration.
4. Presence of long-standing unhealed wounds or fractures or undergoing major surgical resections within 60 days preceding the first day of drug administration.
5. Presence of any severe or uncontrolled coexisting diseases, including but not limited to:

   * Uncontrolled hypertension
   * History of interstitial lung disease or non-infectious pneumonia
   * Active hepatitis B or C, syphilis, or other active and uncontrolled infections
   * Cardiac insufficiency (NYHA≥2)
   * Renal dysfunction requiring dialysis
   * Active autoimmune disease
   * History of acquired or congenital immunodeficiency diseases
6. Occurrence of serious arterial/venous thrombotic events within 6 months prior to the first day of drug administration.
7. History of psychotropic substance abuse or inability to quit, or patients with psychotic disorders.
8. Allergy to study drugs.
9. Patients deemed unsuitable for participation due to severe comorbidities or other reasons determined by the investigators.

Where this trial is running

Shanghai

• Shanghai Chest Hospital — Shanghai, China (Recruiting)

Study contacts

• Principal investigator: Wen Yu, M.D — Shanghai Chest Hospital
• Study coordinator: Wen Yu, M.D

Conditions Esophageal Squamous Cell Carcinoma; Unresectable Locally Advanced Esophageal Cancer; Immunotherapy; Induction immunochemotherapy; Concurrent Immuno-Chemoradiotherapy; Unresectable locally advanced esophageal cancer