Combining low-dose radiotherapy with immunochemotherapy for esophageal cancer

Low-Dose Involved-Field Radiotherapy Combined with Immunochemotherapy for Locally Advanced, Unresectable Esophageal Squamous Cell Carcinoma: a Prospective, Single-Arm, Phase II Study.

This study is testing if combining low-dose radiation with a new type of chemotherapy can help people with advanced esophageal cancer feel better and live longer.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 41 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Sichuan University (other)
• Drugs / interventions: chemotherapy, camrelizumab
• Locations: 1 site (Chengdu, Sichuan)
• Trial ID: NCT06603402 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of low-dose involved-field radiotherapy combined with immunochemotherapy in patients with locally advanced, unresectable esophageal squamous cell carcinoma (ESCC). Participants will receive a treatment regimen that includes low-dose radiotherapy and a chemotherapy regimen with paclitaxel or nab-paclitaxel, carboplatin, and camrelizumab. The study aims to determine if this combination can reduce treatment-related side effects and improve progression-free and overall survival rates. Patients will be monitored regularly after treatment to assess outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-80 with locally advanced, unresectable ESCC who are unsuitable for surgery.

Not a fit: Patients with a history of fistula formation or high risk of gastrointestinal complications may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to reduced side effects and improved survival rates for patients with advanced esophageal cancer.

How similar studies have performed: Other studies have shown promise in combining radiotherapy with immunotherapy, suggesting potential for success in this novel approach.

Eligibility criteria

Inclusion Criteria:

* Age 18-80 years
* Patients with locally advanced, unresectable ESCC who have received radical treatment (radical chemoradiotherapy or radical radiochemotherapy), including:

Cervical esophagus involvement, T4 stage, supraclavicular lymph node metastasis, or inability to tolerate or refusal of surgery due to personal reasons; Failure of neoadjuvant or conversion therapy;Unresectable local recurrence after surgery (with measurable target lesions)

* No evidence of tumor recurrence or metastasis on follow-up examination 2-3 weeks after radical treatment
* Ability to provide fresh tumor tissue specimens (baseline)
* Normal function of major organs
* Performance Status (PS) score ≤ 1
* Patients of childbearing potential must agree to use contraception.
* Voluntary participation with signed informed consent

Exclusion Criteria:

* History of fistula formation due to primary tumor invasion
* High risk of gastrointestinal bleeding, esophageal fistula, or esophageal perforation.
* Poor nutritional status
* Previous immune-related adverse events during prior radical treatment, including grade ≥3 immune-related pneumonitis, myocarditis, etc
* Presence of symptoms or signs of interstitial disease
* Patients with any severe and/or uncontrolled medical condition
* Presence of concurrent malignancies
* Presence of other autoimmune diseases or long-term use of immunosuppressants or corticosteroids.
* Patients who are difficult to communicate with or are unlikely to comply with long-term follow-up.
* Any other conditions that the investigator deems unsuitable for participation.

Where this trial is running

Chengdu, Sichuan

• West China Hospital of Sichuan University — Chengdu, Sichuan, China (RECRUITING)

Study contacts

• Principal investigator: zhenyu ding, MD — West China Hospital, Sichuan University, China
• Study coordinator: zhenyu ding, MD

Conditions: Esophageal Squamous Cell Carcinoma, Immunotherapy, Radiotherapy, immunotherapy