Consolidation of Toripalimab After Chemoradiotherapy in Elderly Esophageal Cancer (EC-CRT-007)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age70-85
SponsorSun Yat-sen University
About this trial
Although definitive chemoradiotherapy (CRT) is the standard treatment option for unresectable locally advanced esophageal cancer, elderly patients tolerate intravenous concurrent CRT less well with age and comorbidities. Previous trials have demonstrated that CRT with oral S-1 was tolerable and provided significant survival benefits over radiotherapy alone in elderly patients with esophageal squamous cell carcinoma (ESCC). However, as high as 54% of patients with elderly ESCC experienced locoregional or distant recurrence after CRT. Therefore, a more effective regimen for older patients is needed. Immune checkpoint inhibitors targeting PD-1/PD-L1 have shown substantial clinical benefits in advanced esophageal cancer. Recently, the combination of immunotherapy with CRT has emerged as a promising strategy to improve clinical outcomes in locally advanced esophageal cancer. The aim of this study was to evaluate the efficacy and safety of toripalimab (an anti-PD-1 antibody) after concurrent CRT in elderly patients with locally advanced ESCC.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Histologically confirmed squamous cell carcinoma of the esophagus;
Locally advanced, and absence of hematogenous metastasis disease according to UICC TNM version 8;
Not suitable for surgery (either for medical reasons or patient's choice);
Age at diagnosis 70 to 85 years;
Disqualifiers
Patients who have been treated previously with anti-tumor therapy (including chemotherapy, radiotherapy, surgery, immunotherapy, etc.);
Patients with hematogenous metastasis disease or esophageal fistula at diagnosis;
Known or suspected allergy or hypersensitivity to monoclonal antibodies, any ingredients of cadonilimab, and the chemotherapeutic drugs paclitaxel or cisplatin;
Patients who have a preexisting or coexisting bleeding disorder;
Trial design
Design model
Parallel
Treatments tested in this trial
S-1
DrugPatients received S-1 administration, 70mg/m2 per day, orally on days 1 to 14 and 29 to 42 during radiotherapy.
Toripalimab
DrugPatients received toripalimab 240 mg every 3 weeks for up to 16 cycles.
Intensity-modulated radiotherapy
RadiationAll patients received external-beam radiation using intensity-modulated radiotherapy. The prescribed dose is 54 Gy in 27 fractions over 5-6 weeks.
Treatment groups
140 Participants
are divided into 2 treatment groupsGroup A: The study groupExperimental treatment 3 interventions
Group B: The control groupActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
Progression-free survival
Three-year follow-up from the date of enrollment to the date of disease progression or last follow-up
Time frame
From date of enrollment until the date of death from any cause or the date of first documented disease progression whichever came first, assessed up to 36 months.Secondary outcomes
1
Overall survival
Three-year follow-up from the enrollment to the date of death from any cause or date of lost follow-up
Time frame
From date of enrollment until the date of death from any cause or the date of last follow-up, whichever came first, assessed up to 36 months.2
Clinical complete response
Tumor response was evaluated 13-16 weeks after the completion of treatment based on CT or PET-CT scans, and endoscopy with biopsies.
Time frame
13-16 weeks after the completion of radiotherapy3
Duration of response
From the date of first CR/PR to the date of first PD.
Time frame
From date of first CR/PR to the date of first PD according to RECIST criteria, assessed up to 36 months.4
Treatment-related adverse events
Incidence of treatment-related adverse events as assessed by CTCAE v4.0.
Time frame
From date of enrollment to the date of last follow-up, assessed up to 36 months.Other outcomes
1
Correlation between immune signature and overall survival
The correlation between pretreatment immune signature (PD-L1, CD8, CTLA-4, CD56, and CD68) by mIHC and overall survival.
Time frame
From date of enrollment to the date of last follow-up, assessed up to 36 months.2
Correlation between serum cytokines and overall survival and immune-related adverse events
The correlation between dynamic change of serum cytokines (IL-2R, IL-6, IL-13, IL-8, CCL3, CD40, and CD274) during treatment and survival outcomes and immune-related adverse events.
Time frame
From date of enrollment to the date of last follow-up, assessed up to 36 months.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Sun Yat-sen University
Lead sponsor
Nanfang Hospital, Southern Medical University
Collaborator
Zhujiang Hospital
Collaborator
Fifth Affiliated Hospital, Sun Yat-Sen University
Collaborator
Xiangya Hospital of Central South University
Collaborator
Wuhan University
Collaborator
Source ClinicalTrials.gov