Hepatic Arterial Infusion Chemotherapy Versus Capecitabine as Adjuvant Therapy for Resected Biliary Tract Cancer (HAIC-BTC)
A Prospective, Open-label, Randomized Controlled Clinical Study of Hepatic Arterial Infusion Chemotherapy (HAIC) Versus Capecitabine as Adjuvant Therapy for Biliary Tract Malignancies After Radical Resection
This is a prospective, open-label, randomized controlled clinical study. The purpose of this study is to evaluate the efficacy and safety of Hepatic Arterial Infusion Chemotherapy (HAIC) compared with Capecitabine monotherapy as adjuvant therapy for patients with biliary tract cancer after radical resection.
Patients with histologically confirmed biliary tract cancer (including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder cancer) who have undergone R0 or R1 resection will be enrolled. A total of approximately 90 eligible patients will be randomized in a 1:1 ratio to receive either HAIC (Oxaliplatin plus 5-Fluorouracil) or Capecitabine.
The primary endpoint is Recurrence-Free Survival (RFS). The secondary endpoints include Overall Survival (OS) and safety profiles. This study aims to provide high-level evidence for a more effective adjuvant treatment strategy to reduce recurrence and improve survival for patients with resected biliary tract cancer.
調査の概要
詳細な説明
Background: Biliary tract cancer (BTC) is highly malignant with a high recurrence rate even after radical resection. The BILCAP trial established Capecitabine as the standard of care for adjuvant therapy. However, further improvements in survival are needed. HAIC has shown promising anti-tumor activity in liver malignancies by increasing local drug concentration and reducing systemic toxicity. Our preliminary data suggest the potential benefit of local chemotherapy in biliary tract cancer.
Study Design: This is a prospective, open-label, randomized controlled trial. Patients will be randomized 1:1 into two arms.
Interventions:
HAIC Arm: Patients will receive Oxaliplatin (40 mg/m2 for 2h) followed by 5-Fluorouracil (800 mg/m2 continuous infusion for 22h) on days 1-3 of each 4-week cycle. Treatment will continue for 3-4 cycles.
Capecitabine Arm: Patients will receive oral Capecitabine 1250 mg/m2 twice daily on days 1-14 of each 3-week cycle for 8 cycles.
Follow-up: Patients will be followed up with imaging every 2 cycles during treatment, and then every 2-3 months until disease recurrence, withdrawal of consent, or death. Survival follow-up will continue to assess overall survival.
研究の種類
入学 (推定)
段階
- フェーズ 3
連絡先と場所
研究連絡先
- 名前：Wenlong Zhai, MD
- 電話番号：+86-371-66913095
- メール：fcczhaiwl@zzu.edu.cn
研究場所
-
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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：+86-371-66913095
- メール：fcczhaiwl@zzu.edu.cn
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Age ≥ 18 years, male or female.
Histopathologically confirmed biliary tract malignancy (intrahepatic cholangiocarcinoma, perihilar cholangiocarcinoma, gallbladder cancer, and distal cholangiocarcinoma) and underwent radical surgery with negative surgical margins.
No history of other tumors, and no prior anti-tumor therapy (including but not limited to chemotherapy, immunotherapy, radiotherapy, targeted therapy, etc.) before or after surgery.
ECOG performance status: 0~1.
Baseline blood counts and biochemistry must meet: hemoglobin ≥ 80 g/L; absolute neutrophil count ≥ 1.5 × 10^9/L; platelet count ≥ 60 × 10^9/L; ALT/AST ≤ 3 times ULN; total bilirubin ≤ 2 times ULN; serum creatinine ≤ 1.5 times ULN; albumin ≥ 30 g/L; INR < 1.7 or PT prolonged ≤ 4 seconds.
Women of childbearing potential must agree to use contraception during the study and for 6 months after; negative pregnancy test within 7 days prior to enrollment; non-lactating. Men must agree to use contraception.
Patients with active HBV infection must receive anti-HBV therapy starting from screening and willing to continue; HCV RNA positive patients must receive standard antiviral therapy and liver function within CTCAE grade 1 elevation.
Voluntary participation, signed informed consent, good compliance, willing to cooperate with follow-up.
Exclusion Criteria:
- Pregnant or lactating.
Received anti-tumor drug therapy for cholangiocarcinoma before or after surgery.
Cardiac, pulmonary, or renal insufficiency, severe hepatic insufficiency (Child-Pugh C): (1) severe cardiovascular diseases; (2) severe respiratory diseases; (3) renal disease: chronic renal failure, MDRD ≥ stage III; (4) uncontrolled active infection; (5) ASA > 3; (6) BMI ≥ 35.
Active gastrointestinal bleeding, ulcer, refractory ascites.
Uncorrectable hypertension, coagulopathy, or severe portal hypertension.
Tumor recurrence within 1 month after surgery.
History of other malignancies.
Received other investigational drugs within 28 days.
Deemed unsuitable by the investigator.
Allergy & Contraindications: severe allergy to iodine contrast media unmanageable by premedication, or contraindications to angiography.
Postoperative pathology confirmed non-cholangiocarcinoma.
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：ランダム化
- 介入モデル：並列代入
- 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：Experimental: HAIC Group
Oxaliplatin (40 mg/m2 for 2h) followed by 5-Fluorouracil (800 mg/m2 continuous infusion for 22h) on days 1-3 of each 4-week cycle for 3-4 cycles. |
Administered via hepatic arterial infusion (HAI) at 40 mg/m2 for 2 hours on days 1-3 of each 4-week cycle. Administered via hepatic arterial infusion (HAI) at 800 mg/m2 continuous infusion for 22 hours on days 1-3 of each 4-week cycle.
他の名前：
|
|
アクティブコンパレータ：Active Comparator: Capecitabine Group
Oral Capecitabine 1250 mg/m2 twice daily on days 1-14 of each 3-week cycle for 8 cycles. |
Administered orally at 1250 mg/m2 twice daily on days 1-14 of each 3-week cycle for 8 cycles.
他の名前：
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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 |
|---|---|---|
|
Recurrence-Free Survival (RFS)
時間枠：From surgery up to 36 months
|
Time from surgery to the first documented recurrence of disease or death from any cause. |
From surgery up to 36 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 randomization up to 60 months
|
Time from randomization to death from any cause. |
From randomization up to 60 months
|
|
Incidence and severity of adverse events
時間枠：From first dose up to 30 days after the last dose
|
Incidence, nature, and severity of adverse events (including serious adverse events) and drug exposure, graded according to NCI CTCAE v5.0. |
From first dose up to 30 days after the last dose
|
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
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- ZZU-HAIC-2026-001
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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