This is an open-label, randomized, controlled, multicenter, phase III clinical study designed to evaluate the efficacy and safety of TT-00420 tablets as monotherapy versus chemotherapy in subjects with unresectable advanced or metastatic intrahepatic cholangiocarcinoma harboring FGFR2 gene fusions/rearrangements or mutations, who have experienced recurrence or progression after prior first-line systemic chemotherapy.
≥ 18 years of age at the time of signing the informed consent form (ICF).
Histologically or cytologically confirmed intrahepatic cholangiocarcinoma.
Subjects diagnosed with stage III or IV intrahepatic cholangiocarcinoma according to the American Joint Committee on Cancer (AJCC) 8th Edition (2018) staging system, and assessed by the investigator as not eligible for curative surgical resection.
Subjects who have experienced recurrence or progression after receiving only one prior line of systemic chemotherapy combined with immunotherapy (PD-1/PD-L1 inhibitor), with or without targeted therapy. Sequential immunotherapy following the completion of chemotherapy cycles is also considered part of the first-line combined regimen. First-line systemic chemotherapy is defined as gemcitabine/capecitabine with or without a platinum-based agent.
Subjects with a history of prior treatment with TT-00420 tablets.
Subjects with a known severe allergic reaction to any agent in the study and for whom no alternative study treatment is available.
Subjects receiving corticosteroid therapy for CNS metastases are also ineligible.
Concurrent active malignancy requiring active treatment. Malignancies diagnosed >5 years ago without the need for treatment, as well as cured localized tumors such as basal cell carcinoma of the skin, carcinoma in situ of the cervix, or papillary thyroid carcinoma, are allowed.
Parallel
TT-00420 (tinengotinib)
DrugSubject will receive TT-00420 (tinengotinib) once daily in 28-day cycles with initial dosage of 10 mg QD per protocol defined schedule.
Oxaliplatin, fluorouracil, calcium folinate, irinotecan, capecitabine
DrugSubjects will receive chemotherapy (mFOLFOX regimen, XELIRI regimen, or irinotecan monotherapy). The dosing schedule involves intravenous administration or oral intake every two weeks (except for capecitabine). Treatment continues until the occurrence of confirmed disease progression, intolerable toxicities, withdrawal of informed consent, death, or other reasons specified in the protocol (whichever occurs first). Among these, subjects receiving the mFOLFOX regimen are limited to a maximum of 6 treatment cycles (approximately 12 administrations).
PFS by BICR
Progression-free survival (PFS) by BICR: PFS is defined as the time from date of randomization to the date of first documented disease progression as assessed by BICR per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or date of death due to any cause, whichever is earlier.
Overall Survival (OS)
OS is defined as the time from date of randomization to date of death of any cause.
PFS by Investigators per RECIST v1.1.
PFS is defined as the time from date of randomization to the date of first documented disease progression as assessed by investigators per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Objective Response Rate (ORR) by BICR and by Investigator
The proportion of subjects who achieved a complete response (CR) or a partial response (PR) based on RECIST version 1.1.
Duration of Response (DOR) by BICR and by Investigator
Duration of response for CR or PR based on RECIST version 1.1.
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