A Prospective, Single-Arm, Open-Label Clinical Study of the Efficacy and Safety of Hepatic Arterial Infusion Chemotherapy Combined With Targeted Therapy and a PD-1 Inhibitor in Patients With Postoperative Hepatocellular Carcinoma and Microvascular Invasion
調査の概要
状態
条件
研究の種類
入学 (推定)
段階
- フェーズ 4
連絡先と場所
研究連絡先
- 名前:Wenlong Zhai, MD
- 電話番号:+86-371-66862231
- メール:ven0371@126.com
研究場所
-
-
Henan
-
Zhengzhou、Henan、中国、450052
- The First Affiliated Hospital of Zhengzhou University
-
コンタクト:
- Wenlong Zhai, MD
- 電話番号:+86-371-66862231
- メール:ven0371@126.com
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Age 18-80 years, male or female;
- Pathologically confirmed hepatocellular carcinoma, with complete resection of all tumor nodules and negative surgical margins;
- Microvascular invasion (MVI) grade ≥ 1
- No other history of tumors and no preoperative anticancer treatment.
- ECOG: 0-1;
Baseline blood count tests and blood biochemistry must meet the following criteria:
Hemoglobin ≥80 g/L;
Absolute neutrophil count ≥1.5×109/L;
Platelet count ≥50×109/L;
Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤5 times the upper limit of normal (ULN);
Total bilirubin ≤3 times ULN;
Serum creatinine ≤1.5 times ULN;
Albumin ≥28 g/L; prothrombin time (PT) ≤19.5 s;
International normalized ratio (INR) ≤2.3
- Women of childbearing potential must agree to use contraception during the study and for 6 months after the study ends (e.g., intrauterine device, oral contraceptives, or condoms); serum or urine pregnancy test must be negative within 7 days before enrollment, and they must not be breastfeeding; men must agree to use contraception during the study and for 6 months after the study ends;
- Subjects voluntarily participate in this study, sign the informed consent form, are compliant, and cooperate with follow-up.
Exclusion Criteria:
1. Patients with any active autoimmune disease or a history of autoimmune disease (including, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism; patients with vitiligo; patients whose childhood asthma has completely resolved and who require no intervention as adults may be included; asthma requiring bronchodilator intervention for medical management cannot be included);
2. Pregnancy or lactation;
3. Over 80 years old;
4. Prior systemic chemotherapy or radiotherapy;
5. Concomitant malignant pleural effusion or ascites;
6. History of organ transplantation (including autologous bone marrow transplantation and peripheral stem cell transplantation);
7. Concomitant infection requiring anti-infective treatment;
8. Concomitant peripheral nervous system disease or a history of significant psychiatric disease and central nervous system disease;
9. Diagnosis of other types of malignant tumors within 5 years, excluding non-melanoma skin cancer and carcinoma in situ of the cervix;
10. Uncorrectable coagulation disorders;
11. Significant ECG abnormalities or obvious clinical symptoms of heart disease, such as congestive heart failure (CHF), clinically significant coronary heart disease, difficult-to-control arrhythmias, and hypertension;
12. History of myocardial infarction within 12 months, or cardiac function class III or IV;
13. Severe liver disease (e.g., cirrhosis), kidney disease, respiratory disease, uncontrolled diabetes, or other systemic diseases;
14. Individuals deemed unsuitable for inclusion by the investigator.
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
- 主な目的:処理
- 割り当て:なし
- 介入モデル:単一グループの割り当て
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的:HAIC+Targeted Therapy +PD-1 Inhibitor
Hepatic arterial infusion chemotherapy (HAIC): to be performed within 4-8 weeks after liver cancer surgery, as follows: Oxaliplatin 65 mg/m², IA (intra-arterial), Day 1, 0-5 hours: 5-FU 1200 mg/m², IA, maintained for 23 hours. After catheter removal, a pressure dressing for hemostasis for 6-12 hours is sufficient before discharge. The above HAIC treatment will be repeated every 3-4 weeks for a total of 2 cycles. Targeted drugs: Including lenvatinib: oral administration according to body weight; body weight ≥60 kg, 8-12 mg QD; body weight <60 kg, 4-8 mg QD; donafenib: 80 mg BID; apatinib: 250 mg QD. The above targeted drugs will be appropriately adjusted according to the patient's tolerance to toxic side effects. PD-1 inhibitors : sintilimab 200 mg Q3W, ivgtt; camrelizumab 200 mg Q3W, ivgtt; tislelizumab 200 mg Q3W, ivgtt. This study will follow participants for disease recurrence and disease-free survival for at least 2 years. After all participants complete treatment or the |
Oxaliplatin and 5-Fluorouracil(5-FU)administeredvia hepatic artery infusion
Oraltargeted therapy administered daily
PD--1 inhibitor administered viaintravenous infusion
|
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 |
|---|---|---|
|
Disease-free survival (DFS)
時間枠:From the date of randomization until the date of first documented recurrence or death from any cause, whichever came first, assessed up to 28 months.
|
Disease-free survival (DFS) is defined as the time from the date of randomization to the first documented tumor recurrence, metastasis, or death from any cause, whichever occurs first.
|
From the date of randomization until the date of first documented recurrence or death from any cause, whichever came first, assessed up to 28 months.
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Overall survival (OS)
時間枠:From the date of randomization until death from any cause, assessed up to 28 months.
|
Overall survival (OS) is defined as the time from randomization to death from any cause.
For subjects lost to follow-up before death, the time of last follow-up is generally used as the death time.
|
From the date of randomization until death from any cause, assessed up to 28 months.
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Safety endpoints
時間枠:Through study completion, an average of 28 months.
|
Exposure to the investigational drug and the incidence, nature, and severity of adverse events (including serious adverse events) will be recorded.
|
Through study completion, an average of 28 months.
|
協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (推定)
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
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。