Alectinib in Combination With Nivolumab in the Treatment of Recurrent or Refractory HCC Patients … (NCT06354387) | Clinical Trial Compass
CompletedPhase 1
Alectinib in Combination With Nivolumab in the Treatment of Recurrent or Refractory HCC Patients Guided With Serum RNase1 and Tumor Expression of PD-L1
Taiwan5 participantsStarted 2022-02-16
Plain-language summary
Hepatocellular carcinoma (HCC) is the fourth most common cause of cancer-related death and the second most deadly malignancy in Taiwan. Despite decades' intensive studies, surgery and local-regional chemo-embolization, radio-frequency ablation or radiation therapy remain the mainstay of HCC treatments.
Who can participate
Age range20 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Age ≥20 years, at time of signing Informed Consent Form.
✓. Histologically confirmed hepatocellular carcinoma, and the HCC cells harbor only wild-typed ALK.
✓. Who has failed local treatments and at least one line of standard TKI treatment (sorafenib or lenvatinib) and not eligible for immune check point inhibitor treatment.
✓. Life expectancy ≥ 12 weeks
✓. At least one measurable (per RECIST 1.1) lesion. Patients who received prior local therapy (e.g., radiofrequency ablation or transarterial chemoembolization, etc.) are eligible provided the target lesion(s) have not been previously treated with local therapy or the target lesion(s) within the field of local therapy have subsequently progressed in accordance with RECIST version 1.1.
✓. ECOG Performance Status of 0 or 1 within 7 days prior to registration
✓. Child-Pugh class A (see Appendix) or B7-8 within 14 days prior to registration
✓. Adequate hematologic and end-organ function, defined by the following laboratory test results, obtained within 7 days prior to registration, unless otherwise specified:
Exclusion criteria
✕. Intolerant or severe allergic reactions to Alectinib (Alecensa) or Nivolumab (Opdivo)
✕. Symptomatic central nervous system metastases. Brain metastases that have previously been treated and are stable for 4 weeks before the first dose date are allowed.
. Prior treatment with Alectinib (Alecensa) and/or Nivolumab (Opdivo), or prior therapy with an anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibody (or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways) for any reason.
✕. Locoregional HCC therapy (e.g., TACE, RFA), systemic chemotherapy, hormonal therapy (e.g., tamoxifen) or investigational therapy within 4 weeks (or 5 half-lives, whichever is shorter) prior to Screening.
✕. Life expectancy of less than 12 weeks
✕. Major surgery or significant trauma within 14 days prior to Screening. Minor surgery within 7 days prior to Screening (excluding the placement of central/peripheral lines or skin biopsy).
✕. Not recovered from the acute toxic effects of prior anticancer therapy, radiation or major surgery/significant trauma at Screening.
✕. Major systemic diseases that the investigator considers inappropriate for participation