Radiotherapy in Patients With Metastatic Esophageal Cancer Responding to PD-1 Inhibitor Plus Chemotherapy

Phase

Condition

Esophageal Disorders

Digestive System Neoplasms

Treatment

PD-1 inhibitor

Consolidation Radiation

Salvage Radiation

Clinical Study ID

NCT06084897

BEIR 1

Ages > 18
All Genders

Study Summary

The treatment efficacy for stage IVb esophageal cancer has been improved through chemotherapy combined with immunotherapy recently.

On this basis, the investigators intend to conduct a prospective, multicenter phase II clinical trial to assess whether radiotherapy could further improve the survival of patients with metastatic esophageal cancer responding to PD-1 Inhibitor plus chemotherapy.

Accompanied tissue samples, blood samples and urine samples will be analyzed by molecular biological detection (Including Whole Exome Sequencing and proteomics) to explore potential biomarkers for predicting outcomes, efficacy and toxicity.

Eligibility Criteria

Inclusion

Inclusion Criteria:

≥18 years, any gender

Histologically or cytologically confirmed squamous cell carcinoma of esophagealcancer. The initial clinical stage is IVb (2018 AJCC Cancer Staging Manual, 8thEdition) or recurrent patients with recurrence after radical treatment (radicaltreatment includes surgery and radiotherapy, but the recurrence site cannot belocated in the previous radiotherapy field).

ECOG performance status <= 1. Patients aged 65 years and over need to completeG8 screening or Comprehensive Geriatric Assessment, and the final evaluation isgood;

4.There was no significant abnormality in laboratory routine indicators such asblood routine and liver and kidney function;
5.For patients after definitive or preoperative radiotherapy, no recurrence was inthe prior radiation filed;
6.Expected survival is more than 12 weeks;
7.Informed consent provided;
8.With response to 2-4 cycles of the first-line chemotherapy combined withimmunotherapy.

Exclusion

Exclusion Criteria:

1.Patients with other cancer history except hypopharyngeal carcinoma in situ,non-malignant skin cancer and cervical carcinoma in situ.
2.Received surgery (except ostomy), chemotherapy or other anti-tumor treatmentbefore enrollment；

Active infection currently exists . The following conditions occurred within 6months before randomization: myocardial infarction, cerebrovascular accident,or received gastrointestinal, neurological, cardiopulmonary surgery;

History of allergy to chemotherapy drugs or autoimmune disease;

Participate in other clinical trials at present or within 4 weeks beforeenrollment;

6.There are factors such as high risk of fistula that radiotherapy cannot be safelycarried out as assessed by the radiation oncologist.

Study Design

PD-1 inhibitor

October 16, 2023

October 26, 2028

Study Description

Esophageal cancer (EC) is one of the most common carcinomas with high morbidity and mortality worldwide. More than 30% of the patients were stage IV when diagnosed. Fluoropyrimidine plus platinum-based chemotherapy is recommended as first-line treatment for patients with metastatic EC for approximately four decades, however, only minimal improvement has been reached in overall survival (OS).

Recently, immune checkpoint inhibitors have shown effective antitumor activity in patients with unresectable, advanced or metastatic EC. Several randomized trials have demonstrated the PD-1 inhibitor could further improve the OS in patients with advanced esophageal squamous cell carcinoma (ESCC) on the basis of chemotherapy. Chemotherapy combined with immunotherapy has become one of the the standard treatment modality for metastatic EC.

As reported, for the patients with metastatic lung cancer or EC, locoregional radiotherapy could improve survival, especially in those who responding to systemic therapy. However, high-level evidence is still needed to assess whether these patients can benefit from local radiotherapy.

The efficacy of immunotherapy combined with chemotherapy is obviously better than that of chemotherapy alone. On this basis, locoregional radiotherapy may help those patients with metastatic EC responding to systemic therapy improve local control, relieve the local symptoms, and even improve survival.

Therefore, the investigators intend to conduct a prospective, multicenter phase II trial to assess the efficiency and safety of radiotherapy with chemotherapy and immunotherapy for patients with metastatic EC. Accompanied tissue samples, blood samples and urine samples will be analyzed by molecular biological detection to explore potential biomarkers for predicting outcomes, efficacy and toxicity.

Connect with a study center

Cancer hospital, CAMS
Beijing, Beijing 100021
China
Active - Recruiting

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