About this trial
This is a multi-cohort, single-arm, phase II study of the efficacy and side effects of cisplatin plus gemcitabine in the treatment of PD1 failure or intensive treatment of some rare tumors
Eligibility criteria
Qualifiers
1. Written informed consent was obtained before enrollment. 2. Age ≥18 years old; 3. Patients with corresponding cancer confirmed by histological and/or cytological examination; 4. Consent to treatment; 5. ECOG score: 0-1; 6. Previous PD-1 therapy failure; 7. At least one measurable lesion (≥10 mm on CT scan for non-nodal lesions and ≥15 mm on CT scan for nodal lesions according to RECIST criteria).
Disqualifiers
1. Poor patient compliance; 2. Prior exposure to cisplatin and/or gemcitabine and documented progression 3. With ≥ grade 2 myocardial ischemia or myocardial infarction, arrhythmia (QTc≥470ms), and ≥ grade 2 congestive heart failure (New York Heart Association [NYHA] classification); 4. Severe active or uncontrolled infection (≥CTCAE grade 2 infection) requiring systemic antibacterial, antifungal, or antiviral therapy, including pulmonary tuberculosis infection.
Trial design
Treatments tested in this trial
- cisplatin-based chemotherapy
Treatment groups
Sponsors and collaborators
Sheng Zhang
Lead sponsor
Fudan University
Sponsor institution