A Phase 2 interventional study of low-dose involved-field radiotherapy combined with immunochemotherapy in Esophageal Squamous Cell Carcinoma (ESCC) and Immunotherapy, sponsored by Sichuan University. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-12-03.
Sponsored by Sichuan University · Phase 2, Interventional, and Treatment
The aim of this clinical trial is to evaluate whether low-dose involved-field radiotherapy combined with immunochemotherapy can reduce treatment-related adverse effects, enhance progression-free survival (PFS), and improve overall survival (OS) in patients with locally advanced, unresectable esophageal squamous cell carcinoma.
The key questions this study seeks to address are:
Participants in the study will:
This is a single-arm, single-center, prospective clinical study aimed at evaluating the efficacy and safety of low-dose involved-field radiotherapy combined with immunochemotherapy in patients with locally advanced, unresectable esophageal squamous cell carcinoma (ESCC). The study will enroll subjects with pathologically confirmed ESCC (via histology or cytology), clinically staged as cT1-4aN+M0, who are deemed unsuitable for surgical intervention by the investigators or have declined surgical treatment.
Initially, patients will receive one cycle of induction immunochemotherapy consisting of paclitaxel or nab-paclitaxel plus carboplatin, in combination with camrelizumab administered at 200 mg intravenously every three weeks. On the first day of the second chemotherapy cycle, low-dose involved-field radiotherapy will commence. The radiotherapy protocol involves a total dose of 45.0 Gy delivered in 25 fractions of 1.8 Gy each (45.0 Gy/1.8 Gy per fraction over 25 fractions). The clinical target volume (CTV) is defined by extending the gross tumor volume (GTV) 3 cm superiorly and inferiorly, and 0.5 cm anteriorly, posteriorly, and laterally; for involved lymph nodes (GTVn), a 0.5 cm margin is added in all directions.
Following disease stabilization, patients will continue with maintenance therapy using camrelizumab monotherapy for up to one year or until disease progression, as assessed by RECIST 1.1 criteria, or the emergence of intolerable adverse effects. Upon completion of treatment, subjects will undergo routine follow-up according to standard care protocols to document survival status and long-term adverse reactions.
The study utilizes a historical control one-year progression-free survival (PFS) rate of 34% from definitive chemoradiotherapy in locally advanced ESCC. It is hypothesized that the combination of camrelizumab with dual-agent chemotherapy (paclitaxel or nab-paclitaxel plus carboplatin) and sequential low-dose involved-field radiotherapy will improve the 12-month PFS rate to 52%. Based on a two-sided significance level (α) of 0.05 and a power (1-β) of 80%, the required sample size is calculated to be 37 patients. Accounting for a 10% dropout rate, a total of 41 patients will be enrolled in the study.
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's planned enrollment of 41 is close to the median of 45 across 5,170 interventional studies indexed under Carcinoma.
Browse Carcinoma studies →Sichuan University is the lead sponsor of 106 studies on the registry; 65 are open to participants now.
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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)
Exclusion Criteria:
low-dose involved-field radiotherapy combined with immunochemotherapy
Radiation: low-dose involved-field radiotherapy combined with immunochemotherapy
low-dose involved-field radiotherapy combined with immunochemotherapy
The safety of low-dose involved-field radiotherapy combined with immunochemotherapy
This study will collected any adverse medical events that occurred during the study drug treatment, and the treatment-related adverse events as assessed by\" CTCAE v5.0\".
Time frame: 12months
The efficacy of low-dose involved-field radiotherapy combined with immunochemotherapy
The 1-year Progression-free survival (PFS) rate will be evaluated as the primary endpoint using RECIST 1.1 criteria.
Time frame: 12months
The efficacy of low-dose involved-field radiotherapy combined with immunochemotherapy
Evaluate objective response rate (ORR) using the RECIST 1.1 criteria
Time frame: 12months
The efficacy of low-dose involved-field radiotherapy combined with immunochemotherapy
Using the RECIST1.1 tumor evaluation criteria for efficacy evaluation, evaluate overall survival (OS)
Time frame: 24months
Plan to share: No
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Sichuan University