Biliary Tract CancerPhase 3HAIC-BTCNCT07916844
Hepatic Arterial Infusion Chemotherapy Versus Capecitabine as Adjuvant Therapy for Resected Biliary Tract Cancer
A Phase 3 study testing Oxaliplatin, 5-Fluorouracil and Capecitabine in people with Biliary Tract Cancer and Cholangiocarcinoma, run by Zhai Wenlong at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Biliary Tract Cancer, Cholangiocarcinoma, Gallbladder Cancer
- What is being tested?
- Oxaliplatin, 5-Fluorouracil and Capecitabine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 30 Nov 2026to 30 Dec 2031
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
Wenlong Zhai, MD, +86-371-66913095, fcczhaiwl@zzu.edu.cn
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Biliary Tract Cancer, Cholangiocarcinoma, Gallbladder Cancer
- Being tested
- Oxaliplatin, 5-Fluorouracil, Capecitabine
- Keywords
- Hepatic Arterial Infusion Chemotherapy, HAIC, Capecitabine, Adjuvant Therapy
- Medical subject headings
- Biliary Tract Neoplasms, Cholangiocarcinoma, Gallbladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxaliplatinDrug
Administered via hepatic arterial infusion (HAI) at 40 mg/m2 for 2 hours on days 1-3 of each 4-week cycle.
5-FluorouracilDrug
Also called 5-FU
Administered via hepatic arterial infusion (HAI) at 800 mg/m2 continuous infusion for 22 hours on days 1-3 of each 4-week cycle.
CapecitabineDrug
Also called Xeloda
Administered orally at 1250 mg/m2 twice daily on days 1-14 of each 3-week cycle for 8 cycles.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: HAIC Group | Experimental | 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. Receives: Drug: Oxaliplatin; Drug: 5-Fluorouracil |
| Active Comparator: Capecitabine Group | Active comparator | Oral Capecitabine 1250 mg/m2 twice daily on days 1-14 of each 3-week cycle for 8 cycles. Receives: Drug: Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence-Free Survival (RFS)
Time from surgery to the first documented recurrence of disease or death from any cause.
Measured: From surgery up to 36 months
Secondary outcomes (2)
Overall Survival (OS)
Time from randomization to death from any cause.
Measured: From randomization up to 60 months
Incidence and severity of adverse events
Incidence, nature, and severity of adverse events (including serious adverse events) and drug exposure, graded according to NCI CTCAE v5.0.
Measured: From first dose up to 30 days after the last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2026
- Study start30 Nov 2026 (estimated)
- Primary completion30 Dec 2029 (estimated)
- Study completion30 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary Tract CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhai Wenlong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhai Wenlong, The First Affiliated Hospital of Zhengzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07916844
- Sponsor's protocol ID
- ZZU-HAIC-2026-001
- Acronym
- HAIC-BTC
- Status last verified
- Oct 2026
- First submitted
- 29 Oct 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07916844
- Acronym / sponsor ID
- HAIC-BTC / ZZU-HAIC-2026-001
- Conditions
- Biliary Tract Cancer, Cholangiocarcinoma, Gallbladder Cancer
- Keywords
- Hepatic Arterial Infusion Chemotherapy, HAIC, Capecitabine, Adjuvant Therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Zhai WenlongUniversity, hospital or other
- Study start
- 30 Nov 2026 (estimated)
- Primary completion
- 30 Dec 2029 (estimated)
- Study completion
- 30 Dec 2031 (estimated)
- First posted
- 4 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: HAIC Group | Experimental | Drug: Oxaliplatin, Drug: 5-FluorouracilOxaliplatin (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. |
| Active Comparator: Capecitabine Group | Active comparator | Drug: CapecitabineOral Capecitabine 1250 mg/m2 twice daily on days 1-14 of each 3-week cycle for 8 cycles. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OxaliplatinAdministered via hepatic arterial infusion (HAI) at 40 mg/m2 for 2 hours on days 1-3 of each 4-week cycle. | Drug | Experimental: HAIC Group |
| 5-FluorouracilAlso: 5-FUAdministered via hepatic arterial infusion (HAI) at 800 mg/m2 continuous infusion for 22 hours on days 1-3 of each 4-week cycle. | Drug | Experimental: HAIC Group |
| CapecitabineAlso: XelodaAdministered orally at 1250 mg/m2 twice daily on days 1-14 of each 3-week cycle for 8 cycles. | Drug | Active Comparator: Capecitabine Group |
Primary outcome
Recurrence-Free Survival (RFS)
Time frame: From surgery up to 36 months
Time from surgery to the first documented recurrence of disease or death from any cause.
2 secondary outcomes
Overall Survival (OS)
Time frame: From randomization up to 60 months
Incidence and severity of adverse events
Time frame: From first dose up to 30 days after the last dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Oxaliplatin, 5-Fluorouracil and Capecitabine in people with Biliary Tract Cancer and Cholangiocarcinoma, run by Zhai Wenlong at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wenlong Zhai, MD (+86-371-66913095, fcczhaiwl@zzu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence-Free Survival (RFS) (time frame: From surgery up to 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.