Abstract 1928P
Background
PDTC/ATC are rare subtype cancers of thyroid cancer with a poor prognosis. Immune-checkpoint inhibitor (ICI) combined with antiangiogenic therapy have the potential for synergistic activity through modulation of the microenvironment. We report the activity and safety of camrelizumab plus apatinib mesylate in patients with recurrent or metastatic PDTC/ATC.
Methods
In this single-center, open-label, single-arm, phase II trial, we enrolled participants (≥18 years) with recurrent or metastatic PDTC/ATC who were treatment-naive to ICI, regardless of PD-ligand 1 (PD-L1) expression and BRAF gene mutation. Patients received camrelizumab 200 mg every 3 weeks and apatinib 250 mg once per day or 1-5 days every week. The primary end point was objective response rate (ORR) and disease control rate (DCR) assessed by independent radiologists per RECIST version 1.1.
Results
21 patients were enrolled from April 9, 2020 to October 26, 2023. The median age was 61.0 years (range, 47-81). 14 patients were males (66.7%) and 7 females (33.3%). The Eastern Cooperative Oncology Group performance status score was 0 in 6 patients (28.6%), 1 in 10 patients (47.6%). and 2 in 5 patients (23.8%). The pathological diagnosis was PDTC in 12 patients (57.1%), ATC in 6 patients (28.6%), and mixed subtype thyroid cancer (MSTC) involved PDTC and ATC in 3 patients (14.3%). 15 patients underwent efficacy evaluation, including 8 partial response, 1 stable disease, and 6 progression disease. The objective response rate was 53.3%, and the disease control rate was 60%. The most common adverse events were grade 1-2. No patients experienced grade 4 adverse events.
Conclusions
Camrelizumab combined with apatinib mesylate had promising antitumor activity and manageable toxicities in recurrent or metastatic PDTC/ATC.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Jiangsu Hengrui Pharmaceuticals Co.,Ltd.
Disclosure
All authors have declared no conflicts of interest.
Resources from the same session
1475TiP - Fruquintinib in combination with sintilimab and CAPEOX as first-line treatment for advanced G/GEJ cancer: A phase Ib/II clinical trial (FUNCTION)
Presenter: Bei-Bei Chen
Session: Poster session 18
1505P - Exploratory biomarker analysis of the NEONAX trial for response prediction to perioperative (PO) and adjuvant (A) Gem-nabPac chemotherapy (CTX) in resectable PDAC patients (rPDAC Pts)
Presenter: Anton Lahusen
Session: Poster session 18
1506P - ctDNA testing based on deep NGS predicts treatment efficacy and prognosis in advanced pancreatic cancer patients
Presenter: Tingting You
Session: Poster session 18
1507P - Revolutionizing clinical trials: Harnessing artificial intelligence for optimized phase III studies in pancreatic cancer
Presenter: Marie-Edith Bonneterre
Session: Poster session 18
1509P - Cytokines and ductal pancreatic adenocarcinoma: Exploring their relationship with prognosis and molecular subtypes
Presenter: Laura Gutierrez Sainz
Session: Poster session 18
1510P - Exploration of circulating free bacterial DNA as a biomarker for therapy response in metastatic and locally advanced pancreatic cancer patients treated with systemic chemotherapy
Presenter: Sai Surendran
Session: Poster session 18
1511P - The influence of intratumoral bacteria and peri-operative antibiotic treatment on the outcome of resected pancreatic cancer patients treated with adjuvant gemcitabine-based chemotherapy
Presenter: Steffen Ormanns
Session: Poster session 18
1512P - The role of pancreaticoduodenectomy for octogenarians with pancreatic cancer
Presenter: Keita Sonoda
Session: Poster session 18
1513P - Impact of symptom and functional burden on survival in pancreatic ductal adenocarcinoma (PDAC)
Presenter: Omali Pitiyarachchi
Session: Poster session 18