This prospective phase Il study is aim to evaluate the efficacy and safety of FGFR inhibitor combined with immune checkpoint inhibitors in FGFR1/2/3 variant advanced solid tumors.
Age ≥ 18 years;
Histologically or cytologically confirmed unresectable advanced solid tumors with failure or intolerance to standard treatments;
At least one measurable lesion per RECIST v1.1 criteria;
Gene testing confirms FGFR1/2/3 variants, including but not limited to mutations, fusions/rearrangements in solid tumors;
Diagnosis of other malignancies within 3 years before the first dose, except for certain treated skin carcinomas and in-situ carcinomas;
Previous treatment with selective FGFR inhibitors;
Receipt of other investigational drugs within 21 days or antitumor drugs within 14 days before the first dose;
Unresolved toxicity from prior treatments unless ≤ Grade 1 or related to alopecia or fatigue;
Single group
Pemigatinib
DrugPemigatinib and immune checkpoint inhibitors
Objective response rate (ORR)
the proportion of patients with tumor shrinkage with CR and PR over 4 weeks.
Disease control rate（DCR）
The proportion of patients with CR, PR and SD.
Progression-free survival （PFS）
PFS was defined as the time from random assignment to progression or death. Patients alive who had not experienced progression as of the analysis cutoff date were censored at the last disease assessment.
Overall survival（OS）
OS was defined as the time from random assignment to death. For patients alive at the data cutoff date, OS was censored at the last follow-up date.
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