Induction Chemoimmunotherapy Combined With Chemoradiotherapy in Esophageal Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences
About this trial
Although unprecedented advances have been made in the field of esophageal cancer in recent decades, the prognosis for patients with locally advanced esophageal squamous cell carcinoma (ESCC) remains extremely poor, accounting for 30-40% of overall survival at 5 year. In recent years, multimodal treatments have proven to be an appropriate therapeutic approach for locally advanced ESCC. Recently, immunotherapy developed rapidly. The purpose of this study was to observe the efficacy and safety of cardonilizumab combined with chemoradiotherapy in the treatment of locally advanced ESCC.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18-80 years old；
Eligible patients were histologically confirmed esophageal squamous cell carcinoma;
Eligible patients were proven locally advanced ESCC (cT1-2N1-3M0-1, cT3/T4N0-3M0-1, M1 was limited to supraclavicular lymph node metastasis）diagnosed by computed tomography [CT] and/or endoscopic ultrasonography [EUS] according to the American Joint Committee on Cancer (AJCC) 8th edition staging system；
ECOG PS score: 0~1；
Disqualifiers
Those combined with other primary malignant tumors other than esophageal cancer (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix);
patients who had previously received other treatments
At the time of diagnosis, there were distant and hematogenous metastases beyond the supraclavicular lymph node region, including retroperitoneal multiple lymph node metastasis, bone metastasis, brain metastasis, lung metastasis, liver metastasis, malignant pleural effusion and ascites
Those who already have esophageal perforation or are at high risk of esophageal perforation
Trial design
Design model
Single group
Treatments tested in this trial
Cardonilizumab
DrugTwo cycles of Inductive therapy： nab-paclitaxel 250mg/ m2+cisplatin 75mg/ m2+Cardonilizumab 10mg/kg，ivgtt，3 weeks per cycle for 2 cycles
Chemoradiotherapy ±immunotherapy
RadiationChemoradiotherapy ± immunotherapy： * PTV: 50-50.4Gy/1.8-2Gy/25-28fractions ②nab-paclitaxel 100mg+cisplatin 25mg/ m2, d1, every 7 days for 3-5 weeks ③Cardonilizumab 10mg/kg，ivgtt，3 weeks per cycle for 2 cycles
Radical surgery
Procedure/SurgerySurgery was evaluated after concurrent chemoradiotherapy according to patients willing and the surgeons' assessment. If patients were accessed with unresectable disease after radiotherapy or refused to receive surgery, Cardonilizumab would be administered for 2 years or until disease progression.
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: Inductive chemoimmunotherapy+chemoradiotherapy±surgeryExperimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
Event-free survival
Time from treatment initiation to locoregional or distant recurrence, or death from any cause.
Time frame
1-yearSecondary outcomes
1
Overall survival
The 1-year OS rate was defined as the proportion of patients who still alive within one year from treatment initiation.
Time frame
1-year2
Adverse events
In terms of adverse events of radiation, chemotherapy and immunotherapy
Time frame
1-year3
Locoregional recurrence free survival
The 1-year rate was defined as the proportion of patients who did not have any locoregional recurrence from treatment initiation.
Time frame
1-year4
Distant metastasis free survival
The 1-year rate was defined as the proportion of patients who did not have any distant metastasis from treatment initiation.
Time frame
1-yearSponsors and contacts
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Source ClinicalTrials.gov