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
Qualifiers
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
Treatments tested in this trial
- SHR-1701+ liposomal irinotecan (II)
Treatment groups
33 Participants
are divided into 1 treatment groupSponsors and collaborators
Zhigang Li
Lead sponsor
Shanghai Chest Hospital
Sponsor institution
Jiangsu HengRui Medicine Co., Ltd.
Collaborator
Source ClinicalTrials.gov