Sintilimab combined with apatinib plus capecitabine in the treatment of unresectable hepatocellular carcinoma: A prospective, open-label, single-arm, phase II clinical study
ObjectiveTo evaluate the efficacy and safety of sintilimab combined with apatinib plus capecitabine in the treatment of unresectable hepatocellular carcinoma (HCC) to provide a more effective first-line treatment for patients with advanced HCC.MethodsThis open-label, prospective, phase II study incl...
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Frontiers Media S.A.
2022-08-01
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| Series: | Frontiers in Immunology |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fimmu.2022.944062/full |
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| author | Dailong Li Dailong Li Lu Xu Lu Xu Lu Xu Jinxing Ji Jinxing Ji Dan Bao Dan Bao Juan Hu Juan Hu Ying Qian Ying Qian Yinjie Zhou Yinjie Zhou Zhuo Chen Zhuo Chen Daojun Li Daojun Li Xiaopeng Li Xiaoling Zhang Hao Wang Changjun Yi Menglu Shi Yaqi Pang Yaqi Pang Siqi Liu Siqi Liu Xinhua Xu Xinhua Xu |
| author_facet | Dailong Li Dailong Li Lu Xu Lu Xu Lu Xu Jinxing Ji Jinxing Ji Dan Bao Dan Bao Juan Hu Juan Hu Ying Qian Ying Qian Yinjie Zhou Yinjie Zhou Zhuo Chen Zhuo Chen Daojun Li Daojun Li Xiaopeng Li Xiaoling Zhang Hao Wang Changjun Yi Menglu Shi Yaqi Pang Yaqi Pang Siqi Liu Siqi Liu Xinhua Xu Xinhua Xu |
| author_sort | Dailong Li |
| collection | DOAJ |
| description | ObjectiveTo evaluate the efficacy and safety of sintilimab combined with apatinib plus capecitabine in the treatment of unresectable hepatocellular carcinoma (HCC) to provide a more effective first-line treatment for patients with advanced HCC.MethodsThis open-label, prospective, phase II study included patients with unresectable HCC who did not receive systematic treatment. The patients were treated with sintilimab (200 mg, intravenous drip, once every 3 weeks) combined with apatinib (250 mg, oral administration, once a day) plus capecitabine (1000 mg/m2, twice a day; after 2 weeks of oral administration, the drug was stopped for 1 week; course of treatment, 3 weeks). The primary endpoint was the objective response rate (ORR). The secondary endpoints included disease control rate (DCR), progression-free survival (PFS), duration of response (DoR), overall survival (OS), and safety.ResultsForty-seven patients (1 lost to follow-up) were enrolled in the study. As of March 1, 2022, the ORR and DCR were 50.0% (95% CI: 34.9–65.1%) and 91.3% (95% CI: 79.2–97.6%), respectively, after blind, independent imaging evaluation. The median follow-up time was 18.7 months (95% CI: 17.2–20.2 months). The median PFS was 9.0 months (95% CI: 7.1–10.9 months). The median DoR was 10.8 months (95% CI: 4.8–16.8 months). The median OS was not reached, and the 1-year OS rate was 71.7% (95% CI: 56.5–84.0%). Only 28.3% (13/46) of patients had grade 3/4 treatment-related adverse events.ConclusionSintilimab combined with apatinib plus capecitabine has good safety and anti-tumor activity as a first-line treatment for unresectable HCC. This is worthy of further multi-center, prospective, randomized, large-sample clinical studies.Clinical Trial Registrationhttps://ClinicalTrials.gov, identifier NCT04411706. |
| first_indexed | 2024-04-13T02:10:55Z |
| format | Article |
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| institution | Directory Open Access Journal |
| issn | 1664-3224 |
| language | English |
| last_indexed | 2024-04-13T02:10:55Z |
| publishDate | 2022-08-01 |
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| series | Frontiers in Immunology |
| spelling | doaj.art-e55bf02a83fb482b9bf4d7bec8b46ad32022-12-22T03:07:18ZengFrontiers Media S.A.Frontiers in Immunology1664-32242022-08-011310.3389/fimmu.2022.944062944062Sintilimab combined with apatinib plus capecitabine in the treatment of unresectable hepatocellular carcinoma: A prospective, open-label, single-arm, phase II clinical studyDailong Li0Dailong Li1Lu Xu2Lu Xu3Lu Xu4Jinxing Ji5Jinxing Ji6Dan Bao7Dan Bao8Juan Hu9Juan Hu10Ying Qian11Ying Qian12Yinjie Zhou13Yinjie Zhou14Zhuo Chen15Zhuo Chen16Daojun Li17Daojun Li18Xiaopeng Li19Xiaoling Zhang20Hao Wang21Changjun Yi22Menglu Shi23Yaqi Pang24Yaqi Pang25Siqi Liu26Siqi Liu27Xinhua Xu28Xinhua Xu29Department of Oncology, Yichang Central People's Hospital and The First College of Clinical Medical Science, China Three Gorges University, Yichang, ChinaTumor Prevention and Treatment Center of Three Gorges University and Cancer Research Institute of Three Gorges University, Yichang, ChinaDepartment of Oncology, Yichang Central People's Hospital and The First College of Clinical Medical Science, China Three Gorges University, Yichang, ChinaTumor Prevention and Treatment Center of Three Gorges University and Cancer Research Institute of Three Gorges University, Yichang, ChinaDepartment of Radiation Oncology and Medical Oncology, Zhongnan Hospital of Wuhan University, Wuhan, ChinaDepartment of Oncology, Yichang Central People's Hospital and The First College of Clinical Medical Science, China Three Gorges University, Yichang, ChinaTumor Prevention and Treatment Center of Three Gorges University and Cancer Research Institute of Three Gorges University, Yichang, ChinaDepartment of Oncology, Yichang Central People's Hospital and The First College of Clinical Medical Science, China Three Gorges University, Yichang, ChinaTumor Prevention and Treatment Center of Three Gorges University and Cancer Research Institute of Three Gorges University, Yichang, ChinaDepartment of Oncology, Yichang Central People's Hospital and The First College of Clinical Medical Science, China Three Gorges University, Yichang, ChinaTumor Prevention and Treatment Center of Three Gorges University and Cancer Research Institute of Three Gorges University, Yichang, ChinaDepartment of Oncology, Yichang Central People's Hospital and The First College of Clinical Medical Science, China Three Gorges University, Yichang, ChinaTumor Prevention and Treatment Center of Three Gorges University and Cancer Research Institute of Three Gorges University, Yichang, ChinaDepartment of Oncology, Yichang Central People's Hospital and The First College of Clinical Medical Science, China Three Gorges University, Yichang, ChinaTumor Prevention and Treatment Center of Three Gorges University and Cancer Research Institute of Three Gorges University, Yichang, ChinaDepartment of Oncology, Yichang Central People's Hospital and The First College of Clinical Medical Science, China Three Gorges University, Yichang, ChinaTumor Prevention and Treatment Center of Three Gorges University and Cancer Research Institute of Three Gorges University, Yichang, ChinaDepartment of Oncology, Yichang Central People's Hospital and The First College of Clinical Medical Science, China Three Gorges University, Yichang, ChinaTumor Prevention and Treatment Center of Three Gorges University and Cancer Research Institute of Three Gorges University, Yichang, ChinaYichang Akeman Pathology and Diagnostics Center, Yichang, ChinaYichang Akeman Pathology and Diagnostics Center, Yichang, ChinaYichang Akeman Pathology and Diagnostics Center, Yichang, ChinaYichang Akeman Pathology and Diagnostics Center, Yichang, ChinaYichang Akeman Pathology and Diagnostics Center, Yichang, ChinaDepartment of Oncology, Yichang Central People's Hospital and The First College of Clinical Medical Science, China Three Gorges University, Yichang, ChinaTumor Prevention and Treatment Center of Three Gorges University and Cancer Research Institute of Three Gorges University, Yichang, ChinaDepartment of Oncology, Yichang Central People's Hospital and The First College of Clinical Medical Science, China Three Gorges University, Yichang, ChinaTumor Prevention and Treatment Center of Three Gorges University and Cancer Research Institute of Three Gorges University, Yichang, ChinaDepartment of Oncology, Yichang Central People's Hospital and The First College of Clinical Medical Science, China Three Gorges University, Yichang, ChinaTumor Prevention and Treatment Center of Three Gorges University and Cancer Research Institute of Three Gorges University, Yichang, ChinaObjectiveTo evaluate the efficacy and safety of sintilimab combined with apatinib plus capecitabine in the treatment of unresectable hepatocellular carcinoma (HCC) to provide a more effective first-line treatment for patients with advanced HCC.MethodsThis open-label, prospective, phase II study included patients with unresectable HCC who did not receive systematic treatment. The patients were treated with sintilimab (200 mg, intravenous drip, once every 3 weeks) combined with apatinib (250 mg, oral administration, once a day) plus capecitabine (1000 mg/m2, twice a day; after 2 weeks of oral administration, the drug was stopped for 1 week; course of treatment, 3 weeks). The primary endpoint was the objective response rate (ORR). The secondary endpoints included disease control rate (DCR), progression-free survival (PFS), duration of response (DoR), overall survival (OS), and safety.ResultsForty-seven patients (1 lost to follow-up) were enrolled in the study. As of March 1, 2022, the ORR and DCR were 50.0% (95% CI: 34.9–65.1%) and 91.3% (95% CI: 79.2–97.6%), respectively, after blind, independent imaging evaluation. The median follow-up time was 18.7 months (95% CI: 17.2–20.2 months). The median PFS was 9.0 months (95% CI: 7.1–10.9 months). The median DoR was 10.8 months (95% CI: 4.8–16.8 months). The median OS was not reached, and the 1-year OS rate was 71.7% (95% CI: 56.5–84.0%). Only 28.3% (13/46) of patients had grade 3/4 treatment-related adverse events.ConclusionSintilimab combined with apatinib plus capecitabine has good safety and anti-tumor activity as a first-line treatment for unresectable HCC. This is worthy of further multi-center, prospective, randomized, large-sample clinical studies.Clinical Trial Registrationhttps://ClinicalTrials.gov, identifier NCT04411706.https://www.frontiersin.org/articles/10.3389/fimmu.2022.944062/fullapatinibcapecitabinefirst-line treatmenthepatocellular carcinomaimmune checkpoint inhibitorssintilimab |
| spellingShingle | Dailong Li Dailong Li Lu Xu Lu Xu Lu Xu Jinxing Ji Jinxing Ji Dan Bao Dan Bao Juan Hu Juan Hu Ying Qian Ying Qian Yinjie Zhou Yinjie Zhou Zhuo Chen Zhuo Chen Daojun Li Daojun Li Xiaopeng Li Xiaoling Zhang Hao Wang Changjun Yi Menglu Shi Yaqi Pang Yaqi Pang Siqi Liu Siqi Liu Xinhua Xu Xinhua Xu Sintilimab combined with apatinib plus capecitabine in the treatment of unresectable hepatocellular carcinoma: A prospective, open-label, single-arm, phase II clinical study Frontiers in Immunology apatinib capecitabine first-line treatment hepatocellular carcinoma immune checkpoint inhibitors sintilimab |
| title | Sintilimab combined with apatinib plus capecitabine in the treatment of unresectable hepatocellular carcinoma: A prospective, open-label, single-arm, phase II clinical study |
| title_full | Sintilimab combined with apatinib plus capecitabine in the treatment of unresectable hepatocellular carcinoma: A prospective, open-label, single-arm, phase II clinical study |
| title_fullStr | Sintilimab combined with apatinib plus capecitabine in the treatment of unresectable hepatocellular carcinoma: A prospective, open-label, single-arm, phase II clinical study |
| title_full_unstemmed | Sintilimab combined with apatinib plus capecitabine in the treatment of unresectable hepatocellular carcinoma: A prospective, open-label, single-arm, phase II clinical study |
| title_short | Sintilimab combined with apatinib plus capecitabine in the treatment of unresectable hepatocellular carcinoma: A prospective, open-label, single-arm, phase II clinical study |
| title_sort | sintilimab combined with apatinib plus capecitabine in the treatment of unresectable hepatocellular carcinoma a prospective open label single arm phase ii clinical study |
| topic | apatinib capecitabine first-line treatment hepatocellular carcinoma immune checkpoint inhibitors sintilimab |
| url | https://www.frontiersin.org/articles/10.3389/fimmu.2022.944062/full |
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