Found 1 Presentation For Request "56p"
56P - Anti-PD1 antibody toripalimab, lenvatinib and gemox chemotherapy as first-line treatment of advanced and unresectable intrahepatic cholangiocarcinoma: A phase II clinical trial
- Jian Zhou (Shanghai, China)
The outcome of advanced intrahepatic cholangiocarcinoma (ICC) remains poor with current gemcitabine-based chemotherapy. This study is to evaluate the survival benefit of anti-PD1 agent toripalimab, lenvatinib in combination with oxaliplatin and gemcitabine (Gemox) chemotherapy.
The study was an open-label, single-arm, phase II trial. Unresectable, locally advanced or metastatic ICC patients (pts) were given 240 mg toripalimab Q3W via intravenous (IV) infusion, 8mg lenvatinib QD orally, and 1g/m2 gemcitabine on Day 1 and Day 8, and 85 mg/m2 oxaliplatin Q3W by IV for 6 cycles. The primary outcome was the objective response rate (ORR). The response was evaluated according to RECIST v1.1. Secondary outcomes included safety, progression-free survival (PFS) and overall survival (OS). Whole exome sequencing was performed on tumor tissues and PD-L1 expression was determined by immunohistochemistry staining.
From May 2019 to Oct 2019, 30 pathologically confirmed advanced ICC pts with a mean age of 56.5 (range, 25-73) years, including 11 women (37%), were enrolled at Zhongshan Hospital, Fudan University (one pt quitted voluntarily). The ORR was 80% (24/30; 95% CI: 61.4%-92.3%), and disease control rate (DCR) was 93.3% (28/30; 95% CI:77.9%-99.2%). One pt achieved a complete response (CR). Two pts with locally metastatic disease were down-staged and they subsequently underwent resection. Median follow-up was 8.4 months by May 1, 2020. 12 pts had disease progression and 4 pts (4/12) have died. The median PFS and OS have not been reached. The median duration of response has not been reached and responses were ongoing in 16/24 (66.7%) pts at data cutoff. 6-months OS rate was 90%. 43% (13/30) of pts experienced Grade 3 or higher adverse events (AEs). ORR was significantly associated with PD-L1 expression and DNA damage repair (DDR)-related mutations in tumor samples.
The combination of toripalimab, lenvatinib with Gemox chemotherapy was tolerable and showed promising ORR in patients with advanced ICC. These findings warrant further study in a large randomized trial.
Clinical trial identification
Legal entity responsible for the study
Zhongshan Hospital, Fudan University.
Has not received any funding.
All authors have declared no conflicts of interest.