Radiotherapy in Patients With Metastatic Esophageal Cancer Responding to PD-1 Inhibitor Plus Chemotherapy
Radiotherapy in Patients With Metastatic Esophageal Cancer Responding to PD-1 Inhibitor Plus Chemotherapy: a Patient Preference Multicenter Randomized Phase II Trial
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
120 participants
Oct 16, 2023
INTERVENTIONAL
Conditions
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
Inclusion Criteria8
- \. ≥18 years, any gender
- \. Histologically or cytologically confirmed squamous cell carcinoma of esophageal cancer. The initial clinical stage is IVb (2018 AJCC Cancer Staging Manual, 8th Edition) or recurrent patients with recurrence after radical treatment (radical treatment includes surgery and radiotherapy, but the recurrence site cannot be located in the previous radiotherapy field).
- \. ECOG performance status \<= 1. Patients aged 65 years and over need to complete G8 screening or Comprehensive Geriatric Assessment, and the final evaluation is good;
- There was no significant abnormality in laboratory routine indicators such as blood routine and liver and kidney function;
- For patients after definitive or preoperative radiotherapy, no recurrence was in the prior radiation filed;
- Expected survival is more than 12 weeks;
- Informed consent provided;
- With response to 2-4 cycles of the first-line chemotherapy combined with immunotherapy.
Exclusion Criteria6
- Patients with other cancer history except hypopharyngeal carcinoma in situ, non-malignant skin cancer and cervical carcinoma in situ.
- Received surgery (except ostomy), chemotherapy or other anti-tumor treatment before enrollment；
- \. Active infection currently exists . The following conditions occurred within 6 months 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 before enrollment;
- There are factors such as high risk of fistula that radiotherapy cannot be safely carried out as assessed by the radiation oncologist.
Interventions
A maximum of six cycles was recommended for chemotherapy. * Fluoropyrimidine (fluorouracil or capecitabine) with carboplatin or cisplatin; * Paclitaxel (or Albumin-bound paclitaxel) with carboplatin or cisplatin.
Nivolumab or Pembrolizumab or Tislelizumab or Serplulimab or Toripalimab or Sintilimab or Camrelizumab
IMRT/VMAT technique. Patients receive radiotherapy once daily, 5 days a week for an average of 5 weeks. Radiotherapy is delivered to achieve a dosage of 49.22Gy/23f or 50Gy/25f to PGTV for lymphnode metastasis only patients and 40.66Gy/19f or 40Gy/20f for organ metastasis patients. Radiation treatment is planned after chemotherapy completed.
IMRT/VMAT technique. Patients receive radiotherapy once daily, 5 days a week for an average of 5 weeks. Radiotherapy is delivered to achieve a dosage of 49.22Gy/23f or 50Gy/25f to PGTV for lymphnode metastasis only patients and 40.66\~49.22Gy/19f \~23f or 40\~50Gy/20\~25f for organ metastasis patients. Radiation treatment is planned after disease progression when recommended by multidisciplinary team.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06084897