A Real-world Study of Immunotherapy Combination Regimens for Treating Liver Cancer in Cold Regions
調査の概要
詳細な説明
研究の種類
入学 (推定)
連絡先と場所
研究場所
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Heilongjiang
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Harbin、Heilongjiang、中国、150081
- Harbin Medical University Cancer Hospital, No. 150 Haping Road, Nangang District, Harbin, Heilongjiang Province, China
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参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
Inclusion Criteria
- Patients with a clinically confirmed diagnosis of primary hepatocellular carcinoma, intrahepatic cholangiocarcinoma, or combined hepatocellular-cholangiocarcinoma, with measurable tumor lesions.
- Patients who have long-term residence in the cold regions of Northeast China, specifically in provinces with an annual mean temperature between 1.6°C and 10°C: Heilongjiang Province, Jilin Province, and selected cities in Liaoning Province.
- Patients who have received an immune-based therapy regimen.
- Patients with complete clinical data who meet the enrollment criteria, retrospectively collected from January 1, 2020, to December 31, 2025.
Exclusion Criteria
- Patients with concurrent other malignancies.
- Patients who are confirmed pregnant or breastfeeding.
- Any other conditions that, in the investigator's judgment, make the patient unsuitable for participation in this study.
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
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Perioperative Therapy Cohort
Patients receiving immune-based combination therapy as neoadjuvant or adjuvant treatment.
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Immunotherapy: PD-1 inhibitors (e.g., pembrolizumab, nivolumab, camrelizumab, sintilimab) and other immune checkpoint inhibitors; PD-L1 inhibitors (e.g., atezolizumab, durvalumab, adebrelimab) and other immune checkpoint inhibitors. Targeted therapy: Lenvatinib, donafenib, sorafenib, apatinib, bevacizumab, and other targeted therapy agents. Chemotherapy: Oxaliplatin-based and other systemic chemotherapy regimens. Locoregional therapy: Transarterial chemoembolization (TACE), hepatic arterial infusion chemotherapy (HAIC), radiofrequency ablation (RFA), microwave ablation (MWA), percutaneous ethanol injection (PEI), cryoablation, external beam radiotherapy (EBRT), and internal radiotherapy. Other regimens selected/recommended by investigators: Including but not limited to traditional Chinese medicine preparations and other antitumor therapies. Treatment options include immunotherapy alone, immunotherapy combined with targeted therapy, or immunotherapy combined with locoregional thera |
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Locoregional Therapy Combined Cohort
Patients receiving immune-based combination therapy combined with locoregional therapies such as ablation, TACE, HAIC, or radiotherapy.
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Immunotherapy: PD-1 inhibitors (e.g., pembrolizumab, nivolumab, camrelizumab, sintilimab) and other immune checkpoint inhibitors; PD-L1 inhibitors (e.g., atezolizumab, durvalumab, adebrelimab) and other immune checkpoint inhibitors. Targeted therapy: Lenvatinib, donafenib, sorafenib, apatinib, bevacizumab, and other targeted therapy agents. Chemotherapy: Oxaliplatin-based and other systemic chemotherapy regimens. Locoregional therapy: Transarterial chemoembolization (TACE), hepatic arterial infusion chemotherapy (HAIC), radiofrequency ablation (RFA), microwave ablation (MWA), percutaneous ethanol injection (PEI), cryoablation, external beam radiotherapy (EBRT), and internal radiotherapy. Other regimens selected/recommended by investigators: Including but not limited to traditional Chinese medicine preparations and other antitumor therapies. Treatment options include immunotherapy alone, immunotherapy combined with targeted therapy, or immunotherapy combined with locoregional thera |
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First-Line Advanced Cohort
Patients with advanced HCC who have received no prior systemic therapy and receive immune-based combination as first-line treatment.
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Immunotherapy: PD-1 inhibitors (e.g., pembrolizumab, nivolumab, camrelizumab, sintilimab) and other immune checkpoint inhibitors; PD-L1 inhibitors (e.g., atezolizumab, durvalumab, adebrelimab) and other immune checkpoint inhibitors. Targeted therapy: Lenvatinib, donafenib, sorafenib, apatinib, bevacizumab, and other targeted therapy agents. Chemotherapy: Oxaliplatin-based and other systemic chemotherapy regimens. Locoregional therapy: Transarterial chemoembolization (TACE), hepatic arterial infusion chemotherapy (HAIC), radiofrequency ablation (RFA), microwave ablation (MWA), percutaneous ethanol injection (PEI), cryoablation, external beam radiotherapy (EBRT), and internal radiotherapy. Other regimens selected/recommended by investigators: Including but not limited to traditional Chinese medicine preparations and other antitumor therapies. Treatment options include immunotherapy alone, immunotherapy combined with targeted therapy, or immunotherapy combined with locoregional thera |
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Later-Line Advanced Cohort
Patients with advanced HCC who have progressed after at least one prior systemic therapy and receive immune-based combination as subsequent treatment.
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Immunotherapy: PD-1 inhibitors (e.g., pembrolizumab, nivolumab, camrelizumab, sintilimab) and other immune checkpoint inhibitors; PD-L1 inhibitors (e.g., atezolizumab, durvalumab, adebrelimab) and other immune checkpoint inhibitors. Targeted therapy: Lenvatinib, donafenib, sorafenib, apatinib, bevacizumab, and other targeted therapy agents. Chemotherapy: Oxaliplatin-based and other systemic chemotherapy regimens. Locoregional therapy: Transarterial chemoembolization (TACE), hepatic arterial infusion chemotherapy (HAIC), radiofrequency ablation (RFA), microwave ablation (MWA), percutaneous ethanol injection (PEI), cryoablation, external beam radiotherapy (EBRT), and internal radiotherapy. Other regimens selected/recommended by investigators: Including but not limited to traditional Chinese medicine preparations and other antitumor therapies. Treatment options include immunotherapy alone, immunotherapy combined with targeted therapy, or immunotherapy combined with locoregional thera |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Overall Survival
時間枠：From start of treatment to death or last follow-up, assessed up to 36 months.
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Time from initiation of immune-based combination therapy to death from any cause
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From start of treatment to death or last follow-up, assessed up to 36 months.
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Real-World Progression-Free Survival (rwPFS)
時間枠：From start of treatment to progression or death, assessed up to 36 months.
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Time from treatment initiation to first documented disease progression or death, based on real-world clinical assessment.
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From start of treatment to progression or death, assessed up to 36 months.
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Real-World Objective Response Rate (rwORR)
時間枠：From start of treatment to end of treatment, assessed up to 36 months.
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Proportion of patients with best overall response of complete response (CR) or partial response (PR) based on real-world clinical assessment.
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From start of treatment to end of treatment, assessed up to 36 months.
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Real-World Best Overall Response (rwBOR)
時間枠：From start of treatment to end of treatment, assessed up to 36 months.
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Best tumor response recorded during treatment, including CR, PR, SD, PD, or NE based on real-world clinical assessment.
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From start of treatment to end of treatment, assessed up to 36 months.
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Real-World Disease Control Rate (rwDCR)
時間枠：From start of treatment to end of treatment, assessed up to 36 months
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Proportion of patients with best overall response of CR, PR, or stable disease (SD) based on real-world clinical assessment.
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From start of treatment to end of treatment, assessed up to 36 months
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Real-World Duration of Response (rwDOR)
時間枠：From first response to progression or death, assessed up to 36 months.
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Time from first documented CR or PR to disease progression or death, assessed in patients who achieved objective response.
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From first response to progression or death, assessed up to 36 months.
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AE Incidence
時間枠：From first dose to 90 days after last dose of immunotherapy or 30 days after last dose of antiangiogenic agents, whichever is later.
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Incidence and severity of adverse events (AEs), serious adverse events (SAEs), and immune-related adverse events (irAEs), graded by NCI-CTCAE v6.0.
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From first dose to 90 days after last dose of immunotherapy or 30 days after last dose of antiangiogenic agents, whichever is later.
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協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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