SHR-1701 in Combination With Irinotecan Liposome (II) for Second-line Treatment of ESCC After Immunotherapy
ConditionESCC
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorZhigang Li
About this trial
This study is a single-arm, exploratory clinical trial aimed at evaluating the efficacy and safety of SHR-1701 in combination with liposomal irinotecan (II) in patients with esophageal squamous cell carcinoma who have received prior immunotherapy. Eligible patients with esophageal cancer will be treated with SHR-1701 in combination with liposomal irinotecan (II).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Signed written informed consent, voluntarily participating in this study;
Histopathologically or cytologically confirmed esophageal squamous cell carcinoma;
Prior treatment with immunotherapy;
At least one measurable lesion as assessed by RECIST version 1.1;
Disqualifiers
1. Active or untreated central nervous system (CNS) metastases (e.g., brain or leptomeningeal metastases) as determined by CT or magnetic resonance imaging (MRI) assessment during screening.
Use of immunosuppressive medications or systemic corticosteroid therapy for immunosuppressive purposes (dose > 10 mg/day prednisone or equivalent) within 2 weeks prior to the first dose of study drug; inhaled or topical steroids and adrenal corticosteroid replacement at doses > 10 mg/day prednisone or equivalent are permitted in the absence of active autoimmune disease.
Receipt of a live attenuated vaccine within 4 weeks prior to the first dose of study drug.
Major surgery or significant traumatic injury within 4 weeks prior to the first dose of study drug.
Trial design
Design model
Single group
Treatments tested in this trial
SHR-1701+ liposomal irinotecan (II)
DrugSHR-1701 in combination with Irinotecan Liposome (II) is administered on Day 1 of each 3-week treatment cycle until disease progression, intolerable toxicity, withdrawal of consent, or a decision by the investigator to discontinue treatment, or until the maximum treatment duration of 2 years has been reached, whichever occurs first.
Treatment groups
33 Participants
are divided into 1 treatment groupGroup A: treatment groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Objective Response Rate
Objective response rate (ORR) defined as the proportion of patients with a best overall response of complete response (CR) or partial response (PR).
Time frame
through study completion, an average of 12 weeksSecondary outcomes
1
Disease Control Rate
Disease Control Rate (DCR) defined as the proportion of patients whose best overall response is CR, PR, or SD.
Time frame
through study completion, an average of 12 weeks2
Progression-Free Survival
Progression-Free Survival defined as the time from the first dose to the first documented disease progression as assessed by the investigator per RECIST version 1.1, or the time from enrollment to death from any cause, whichever occurs first.
Time frame
through study completion, an average of 6 months3
Oearall survival
Overall Survival (OS) Defined as the time from the first dose to death from any cause.
Time frame
through study completion, an average of 12 months4
Safty
Adverse Events (AEs): Incidence and severity (including whether they are serious adverse events or immune-related adverse events), with severity graded according to NCI-CTCAE version 6.0;
Time frame
Documented from the time of signing the informed consent form until the end of the safety follow-up period (Day 90 after the last dose) or the initiation of a new anti-cancer therapy, whichever occurs first.Sponsors and contacts
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Zhigang Li
Lead sponsor
Shanghai Chest Hospital
Sponsor institution
Jiangsu HengRui Medicine Co., Ltd.
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: