Multicenter Single-Arm Study of Ivonescimab (AK112) Combined with Chemotherapy in Pretreated Pleural Mesothelioma
Efficacy and Safety of Ivonescimab (AK112) in Combination with Chemotherapy for the Treatment of Pretreated Pleural Mesothelioma: a Phase II Multicenter, Single-Arm Clinical Trial
Sponsor: The First Hospital of Jilin University
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
objective response rate (ORR)
Time frame: From enrollment to the end of treatment at 3 months
Secondary Endpoints
progression-free survival (PFS)
overall survival (OS)
adverse effect
Eligibility Criteria
Inclusion Criteria: 1. Asian ethnicity, aged 18-75, ECOG 0-1; 2. Histologically confirmed malignant pleural mesothelioma; 3. Progression after ≥1 and ≤2 prior systemic therapies (platinum-based chemotherapy, immunotherapy combinations, or anti-angiogenic therapy); 4. ≥1 measurable lesion (modified RECIST 1.1); 5. Adequate organ function (hemoglobin ≥90g/L, neutrophils ≥1.5×10⁹/L, creatinine clearance ≥50ml/min). Exclusion Criteria: 1. History of other malignancies within 5 years prior to enrollment, except cured basal cell carcinoma, squamous cell carcinoma of the skin, or carcinoma in situ with radical resection. Patients diagnosed with other malignancies or lung cancer more than 5 years prior to enrollment require pathological/cytological confirmation of recurrent lesions. 2. Radiologically confirmed tumor encasement of major blood vessels, necrosis, or cavitation with significant bleeding risk as judged by the investigator. Tumor invasion of adjacent critical organs/vessels (…
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Expert commentary on why this trial matters and what to watch for.
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