Immunotherapy After Radiotherapy in Elderly ESCC
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age75+
SponsorThe Central Hospital of Lishui City
About this trial
The incidence and mortality of esophageal squamous cell carcinoma are at the forefront in China.Most part of patients are elderly. Concurrent chemoradiotherapy is the standard treatment for unresectable locally advanced esophageal squamous cell carcinoma. Most elderly patients cannot tolerate concurrent chemotherapy because of complications and other reasons. Immunotherapy has definite efficacy and low toxicity in advanced esophageal squamous cell carcinoma, and the results combined with radiotherapy have also been preliminarily reported. Therefore, it is necessary to further explore the efficacy and safety of radiotherapy combined with immunotherapy in elderly patients with esophageal squamous cell carcinoma.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥75 years old, regardless of gender；
Esophageal cancer confirmed by histology or cytology；
Unresectable, unable to tolerate or refuse surgery and concurrent chemoradiotherapy；
Unable to tolerate chemotherapy；
Disqualifiers
Synchronous or metachronous second primary malignancy. Participants with basal cell carcinoma of the skin, or cervical cancer in situ that have undergone potentially curative therapy are not excluded from the study;
with multifocal primary esophageal cancer;
The pathological diagnosis was esophageal small cell carcinoma, adenocarcinoma, or mixed carcinoma.
Esophageal squamous cell carcinoma with active bleeding within 2 months of the primary lesion；
Trial design
Design model
Single group
Treatments tested in this trial
Radiotherapy
Radiation95% PGTV56-60Gy/28-30 fractions, 2Gy/1 fractions; 95% PTV50.4-54Gy/28-30 fractions, 1.8Gy/1 fractions; 5 days a week; 6 weeks.
Toripalimab
DrugToripalimab (200 mg, intravenously infused) will be administered as the maintenance treatment every 3 weeks within 4 weeks after the completion of radiotherapy for 1 years or until progression, intolerable toxicity, or physician/patient decision
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Radiotherapy Sequential ToripalimabExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Progression-free survival (PFS)
We aim to evaluate the progression-free survival (PFS) of elderly patients with unresectable esophageal squamous cell carcinoma who were unable to accept concurrent chemotherapy and received sequential treatment with Triptolide injection after radiotherapy alone.
Time frame
2 yearsSecondary outcomes
1
Overall survival (OS)
Overall survival (OS) is defined as the time from treatment to death, regardless of disease recurrence .
Time frame
2 years2
Objective response rate (ORR)
Objective response rate (ORR) is defined as the proportion of patients with a complete response(CR) or partial response(PR) to treatment according to RECIST v1.1.
Time frame
2 years3
Duration of response (DOR)
Duration of response (DOR) was determined from date of initial response to PD according to RECIST v1.1.
Time frame
2 years4
Time to death or distant metastasis (TTDM)
Time to death or distant metastasis (TTDM) according to RECIST v1.1.
Time frame
2 yearsLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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