Biliary Tract Cancer (BTC)NCT07466238
HAIC Plus Systemic Therapy as De-escalation Therapy Strategy for Biliary Tract Cancer
A study testing HAIC(GOLF), Bevacizumab and PD-1/PD-L1 inhibitor in people with Biliary Tract Cancer (BTC), run by Peking University at 2 sites in China.
Trial summary
Biliary tract cancer (BTC), including cholangiocarcinoma and gallbladder cancer (GBC), is a group of malignancies with highly heterogeneous, highly aggressiveness, and poor prognosis. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Biliary Tract Cancer (BTC)
- What is being tested?
- HAIC(GOLF), Bevacizumab and PD-1/PD-L1 inhibitor
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesChina
- Study dates
- 31 Mar 2026to 31 Mar 2029
- Phase
- Interventional
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18-80 years, both genders.
- Diagnosis of biliary tract cancer (including intrahepatic cholangiocarcinoma, perihilar cholangiocarcinoma, and gallbladder cancer) and confirmed by histopathological or cytopathological examination.
- Without distant metastasis or limited distant metastasis
- Treatment-naive.
- ECOG PS score < 2.
- Child-Pugh score: Class A or B (≤7).
- Normal major organ function, meeting the following standards:(1) Blood routine examination:A. Hb≥90 g/L;B. ANC≥1.5×10^9/L;C. PLT≥75×10^9/L;(2) Biochemical examination:A. ALB ≥30g/L;B. ALT and AST<5×ULN;C. TBiL ≤5×ULN;D. Creatinine ≤1.5×ULN;(3) Coagulation function:A. International normalized ratio (INR) ≤1.5×ULN;B. Activated partial thromboplastin time (APTT) ≤1.5×ULN.
Who cannot join
- Coexistent or synchronous malignancies.
- Distal cholangiocarcinoma.
- Allergic to contrast agents or oxaliplatin.
- Pregnant or lactating women.
- Multiple extrahepatic metastases or combined malignant pleural and peritoneal effusions.
- History of organ transplantation.
- With infections requiring anti-infection treatment.
- Severe and irreparable coagulation dysfunction.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Peking University Cancer Hospital
Beijing, 100142
Xiaodong Wang, 8601088196330, xiaodongw75@yahoo.com
- Not yet recruiting
Peking University Cancer Hospital
Beijing
Xiaodong Wang, 0086-18611586227, xiaodongw75@yahoo.com
About this study
Official title: HAIC Combined With Systemic Therapy as De-escalation Therapy Strategy for Biliary Tract Cancer: A Conceptual Study
Biliary tract cancer (BTC), including cholangiocarcinoma and gallbladder cancer (GBC), is a group of malignancies with highly heterogeneous, highly aggressiveness, and poor prognosis. Surgery is recognized as the only curative treatment for BTC, however, only about 20% BTC patients are eligible for curative resection since most patients with BTC are diagnosed at an advanced stage. The median overall survival (OS) in patients with unresectable BTC is typically less than 6 months. For patients with unresectable BTC, gemcitabine plus cisplatin (GemCis) had been recommended as the standard first-line treatment for many years. However, the objective response rate (ORR) of this regimen is only 26.1%, and the survival benefit remains limited, with a median OS of less than one year.
In recent years, two phase III trials (TOPAZ-1 and KEYNOTE-966) have demonstrated that combining immune checkpoint inhibitors (durvalumab or pembrolizumab) with the GemCis regimen could further prolong survival in patients with BTC, achieving a median OS of 12.9 months and 12.7 months, respectively. Based on this evidence, many guidelines worldwide had recommended GemCis plus durvalumab or pembrolizumab as the preferred standard first-line treatment for patients with unresectable BTC. However, survival benefits from this combination therapy remain relatively limited, and tumor response is suboptimal, with an ORR of only 26.7%-29%.
Read more
Hepatic arterial infusion chemotherapy (HAIC) enables continuous infusion of chemotherapeutic agents via the hepatic artery, significantly increasing local drug concentration at the tumor site, maximizing antitumor efficacy, and achieving a higher ORR (50%-60%) with substantial reduction in tumor burden. In recent years, HAIC has been increasingly used in the treatment of unresectable BTC, with its efficacy supported by many clinical studies.
Firstly, HAIC provides survival benefits comparable to surgery in patients with multifocal intrahepatic cholangiocarcinoma (iCCA), and significantly outperforms systemic therapy. In 2022, a retrospective study enrolled 141 patients who received HAIC and 178 patients who underwent surgical resection from 12 centers. The results showed the median OS was 20.3 months in the HAIC group and 18.9 months in the resection group (P = 0.32), indicating comparable survival outcomes between HAIC and surgery. Given the risks of post-hepatectomy complications, HAIC may serve as an effective alternative treatment strategy for multifocal iCCA. Furthermore, for locally advanced unresectable iCCA, the results in a study in 2024 comparing HAIC with GemCis regimen chemotherapy revealed that although patients in the HAIC group had a higher tumor burden (proportion of multifocal disease: 73.4% vs. 55.3%, P = 0.023), the median OS in HAIC group remained significantly superior to that in the GemCis group (27.7 months vs. 11.8 months, P < 0.001).
Secondly, HAIC has also been demonstrated to be effective in treating perihilar cholangiocarcinoma (pCCA). In 2017, a single-arm, prospective phase II trial conducted in our center showed HAIC with oxaliplatin and fluorouracil yielded an ORR of 67.6%, a median progression-free survival (PFS) of 12.2 months, and a median OS of 20.5 months in treating perihilar cholangiocarcinoma (pCCA).
Furthermore, HAIC also has clinical potential in treating advanced GBC. In 2021, a retrospectively study in our center enrolled 26 patients with advanced GBC who received HAIC with oxaliplatin and fluorouracil, of whom 23.1% had failed prior systemic therapy and 34.6% had contraindications to systemic treatment. The results showed that HAIC achieved a median PFS of 10 months and a median OS of 13.5 months, with an ORR of 69.2% and a disease control rate (DCR) of 92.3%.
In recent years, many studies have demonstrated that HAIC combined with systemic therapy could yield significant survival benefits in patients with unresectable BTC. A phase II clinical trial in 2022 evaluated the efficacy of HAIC with floxuridine plus systemic gemcitabine and oxaliplatin (GEMOX) in unresectable iCCA. The results showed that the combination therapy achieved a median PFS of 11.8 months and a median OS of 25 months, with a 6-month DCR of 84%, and 58% of patients achieved partial response (PR). Additionally, the association of benefit of combining HAIC with systemic chemotherapy and stage of BTC has been reported, and that patients with locally advanced cholangiocarcinoma may not derive such benefit from this combination. In 2025, a phase II clinical trial conducted in our center evaluated the efficacy and safety of HAIC (bevacizumab, oxaliplatin, and fluorouracil) combined with toripalimab as a first-line treatment for unresectable BTC. The results showed a median PFS of 13.2 months and a median OS of 19 months, with an ORR as high as 84.38%. Some patients achieved successful conversion resection following this combination therapy, and postoperative pathology confirmed pathological complete res
- Conditions
- Biliary Tract Cancer (BTC)
- Being tested
- HAIC(GOLF), Bevacizumab, PD-1/PD-L1 inhibitor, HAIC (FOLFOX), Gemcitabin
- Keywords
- biliary tract cancer, hepatic arterial infusion chemotherapy, systemic therapy
- Medical subject headings
- Biliary Tract Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HAIC(GOLF)Procedure or surgery
Hepatic arterial chemotherapy consisted of infusions of gemcitabin (1000 mg/m2 for 2 hours, d1), oxaliplatin (35 mg/m2 for 2 hours, d1-2), followed by 5-fluorouracil (750 mg/m2 for 22 hours, d1-2) every 3-4 weeks.
BevacizumabDrug
7.5 mg/kg intravenously before HAIC every 3-4 weeks
PD-1/PD-L1 inhibitorDrug
PD-1/PD-L1 inhibitor injection intravenously or percutaneously every 3-4 week
HAIC (FOLFOX)Procedure or surgery
Hepatic arterial chemotherapy consisted of infusions of oxaliplatin (35 mg/m2 for 2 hours, d1-2), followed by 5-fluorouracil (750 mg/m2 for 22 hours, d1-2) every 3-4 weeks.
GemcitabinDrug
1000 mg/m2 intravenously
De-escalation strategyProcedure or surgery
curative treatment (surgery, ablation, SIRT, or SBRT) or maintenance treatment (S-1, Bevacizumab, and PD-1/PD-L1 inhibitor) when tumor response got CR, PR, or SD
Second-line treatmentProcedure or surgery
Other treatments when tumor response got PD
| Study group | Role | What they receive |
|---|---|---|
| Locally advanced group | Experimental | Patients with BTC at locally advanced stage Receives: Procedure: HAIC(GOLF); Drug: Bevacizumab; Drug: PD-1/PD-L1 inhibitor; Procedure: De-escalation strategy; Procedure: Second-line treatment |
| Advanced group | Experimental | Patients with BTC at advanced stage Receives: Drug: Bevacizumab; Drug: PD-1/PD-L1 inhibitor; Procedure: HAIC (FOLFOX); Drug: Gemcitabin; Procedure: De-escalation strategy; Procedure: Second-line treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
OS
The time from treatment initiation to death due to any cause
Measured: From date of treatment beginning until the date of death from any cause, assessed up to 36 months.
clinical complete response rate
The proportion of participants in the analysis population who have clinical complete response (CR) determined by investigators using mRECIST criteria at any time during the study.
Measured: From date of treatment beginning until the date of first documented progression disease, up to 36 months.
Secondary outcomes (3)
PFS
The time from treatment initiation to the first documented disease progression or death due to any cause, whichever occurs firstly.
Measured: From date of treatment beginning until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months.
ORR
The proportion of participants in the analysis population who have complete response (CR) or partial response (PR) determined by investigators using mRECIST criteria at any time during the study.
Measured: From date of treatment beginning until the date of first documented progression disease, up to 36 months.
Number of patients with treatment-related adverse events
Number of patients with AE, treatment-related AE (TRAE), serious adverse event (SAE) assessed by CTCAE v5.0.
Measured: From date of treatment beginning until the date of study treatment completion, up to 36 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study start31 Mar 2026
- Primary completion31 Mar 2028 (estimated)
- Study completion31 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary Tract Cancer (BTC)Studies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiaodong Wang, Study director, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07466238
- Sponsor's protocol ID
- HOST
- Status last verified
- Apr 2026
- First submitted
- 19 Feb 2026
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HAIC Combined With Systemic Therapy as De-escalation Therapy Strategy for Biliary Tract Cancer: A Conceptual Study
- ClinicalTrials.gov ID
- NCT07466238
- Acronym / sponsor ID
- HOST
- Conditions
- Biliary Tract Cancer (BTC)
- Keywords
- biliary tract cancer, hepatic arterial infusion chemotherapy, systemic therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- 31 Mar 2026 (actual)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 31 Mar 2029 (estimated)
- First posted
- 12 Mar 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.
Biliary tract cancer (BTC), including cholangiocarcinoma and gallbladder cancer (GBC), is a group of malignancies with highly heterogeneous, highly aggressiveness, and poor prognosis. Surgery is recognized as the only curative treatment for BTC, however, only about 20% BTC patients are eligible for curative resection since most patients with BTC are diagnosed at an advanced stage. The median overall survival (OS) in patients with unresectable BTC is typically less than 6 months. For patients with unresectable BTC, gemcitabine plus cisplatin (GemCis) had been recommended as the standard first-line treatment for many years. However, the objective response rate (ORR) of this regimen is only 26.1%, and the survival benefit remains limited, with a median OS of less than one year.
In recent years, two phase III trials (TOPAZ-1 and KEYNOTE-966) have demonstrated that combining immune checkpoint inhibitors (durvalumab or pembrolizumab) with the GemCis regimen could further prolong survival in patients with BTC, achieving a median OS of 12.9 months and 12.7 months, respectively. Based on this evidence, many guidelines worldwide had recommended GemCis plus durvalumab or pembrolizumab as the preferred standard first-line treatment for patients with unresectable BTC. However, survival benefits from this combination therapy remain relatively limited, and tumor response is suboptimal, with an ORR of only 26.7%-29%.
Hepatic arterial infusion chemotherapy (HAIC) enables continuous infusion of chemotherapeutic agents via the hepatic artery, significantly increasing local drug concentration at the tumor site, maximizing antitumor efficacy, and achieving a higher ORR (50%-60%) with substantial reduction in tumor burden. In recent years, HAIC has been increasingly used in the treatment of unresectable BTC, with its efficacy supported by many clinical studies.
Firstly, HAIC provides survival benefits comparable to surgery in patients with multifocal intrahepatic cholangiocarcinoma (iCCA), and significantly outperforms systemic therapy. In 2022, a retrospective study enrolled 141 patients who received HAIC and 178 patients who underwent surgical resection from 12 centers. The results showed the median OS was 20.3 months in the HAIC group and 18.9 months in the resection group (P = 0.32), indicating comparable survival outcomes between HAIC and surgery. Given the risks of post-hepatectomy complications, HAIC may serve as an effective alternative treatment strategy for multifocal iCCA. Furthermore, for locally advanced unresectable iCCA, the results in a study in 2024 comparing HAIC with GemCis regimen chemotherapy revealed that although patients in the HAIC group had a higher tumor burden (proportion of multifocal disease: 73.4% vs. 55.3%, P = 0.023), the median OS in HAIC group remained significantly superior to that in the GemCis group (27.7 months vs. 11.8 months, P < 0.001).
Secondly, HAIC has also been demonstrated to be effective in treating perihilar cholangiocarcinoma (pCCA). In 2017, a single-arm, prospective phase II trial conducted in our center showed HAIC with oxaliplatin and fluorouracil yielded an ORR of 67.6%, a median progression-free survival (PFS) of 12.2 months, and a median OS of 20.5 months in treating perihilar cholangiocarcinoma (pCCA).
Furthermore, HAIC also has clinical potential in treating advanced GBC. In 2021, a retrospectively study in our center enrolled 26 patients with advanced GBC who received HAIC with oxaliplatin and fluorouracil, of whom 23.1% had failed prior systemic therapy and 34.6% had contraindications to systemic treatment. The results showed that HAIC achieved a median PFS of 10 months and a median OS of 13.5 months, with an ORR of 69.2% and a disease control rate (DCR) of 92.3%.
In recent years, many studies have demonstrated that HAIC combined with systemic therapy could yield significant survival benefits in patients with unresectable BTC. A phase II clinical trial in 2022 evaluated the efficacy of HAIC with floxuridine plus systemic gemcitabine and oxaliplatin (GEMOX) in unresectable iCCA. The results showed that the combination therapy achieved a median PFS of 11.8 months and a median OS of 25 months, with a 6-month DCR of 84%, and 58% of patients achieved partial response (PR). Additionally, the association of benefit of combining HAIC with systemic chemotherapy and stage of BTC has been reported, and that patients with locally advanced cholangiocarcinoma may not derive such benefit from this combination. In 2025, a phase II clinical trial conducted in our center evaluated the efficacy and safety of HAIC (bevacizumab, oxaliplatin, and fluorouracil) combined with toripalimab as a first-line treatment for unresectable BTC. The results showed a median PFS of 13.2 months and a median OS of 19 months, with an ORR as high as 84.38%. Some patients achieved successful conversion resection following this combination therapy, and postoperative pathology confirmed pathological complete res
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Locally advanced group | Experimental | Procedure: HAIC(GOLF), Drug: Bevacizumab, Drug: PD-1/PD-L1 inhibitor, Procedure: De-escalation strategy, Procedure: Second-line treatmentPatients with BTC at locally advanced stage |
| Advanced group | Experimental | Drug: Bevacizumab, Drug: PD-1/PD-L1 inhibitor, Procedure: HAIC (FOLFOX), Drug: Gemcitabin, Procedure: De-escalation strategy, Procedure: Second-line treatmentPatients with BTC at advanced stage |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age: 18-80 years, both genders.
- Diagnosis of biliary tract cancer (including intrahepatic cholangiocarcinoma, perihilar cholangiocarcinoma, and gallbladder cancer) and confirmed by histopathological or cytopathological examination.
- Without distant metastasis or limited distant metastasis
- Treatment-naive.
- ECOG PS score < 2.
Key exclusion criteria (8 listed)
- Coexistent or synchronous malignancies.
- Distal cholangiocarcinoma.
- Allergic to contrast agents or oxaliplatin.
- Pregnant or lactating women.
- Multiple extrahepatic metastases or combined malignant pleural and peritoneal effusions.
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 |
|---|---|---|
| HAIC(GOLF)Hepatic arterial chemotherapy consisted of infusions of gemcitabin (1000 mg/m2 for 2 hours, d1), oxaliplatin (35 mg/m2 for 2 hours, d1-2), followed by 5-fluorouracil (750 mg/m2 for 22 hours, d1-2) every 3-4 weeks. | Procedure or surgery | Locally advanced group |
| Bevacizumab7.5 mg/kg intravenously before HAIC every 3-4 weeks | Drug | Advanced group, Locally advanced group |
| PD-1/PD-L1 inhibitorPD-1/PD-L1 inhibitor injection intravenously or percutaneously every 3-4 week | Drug | Advanced group, Locally advanced group |
| HAIC (FOLFOX)Hepatic arterial chemotherapy consisted of infusions of oxaliplatin (35 mg/m2 for 2 hours, d1-2), followed by 5-fluorouracil (750 mg/m2 for 22 hours, d1-2) every 3-4 weeks. | Procedure or surgery | Advanced group |
| Gemcitabin1000 mg/m2 intravenously | Drug | Advanced group |
| De-escalation strategycurative treatment (surgery, ablation, SIRT, or SBRT) or maintenance treatment (S-1, Bevacizumab, and PD-1/PD-L1 inhibitor) when tumor response got CR, PR, or SD | Procedure or surgery | Advanced group, Locally advanced group |
| Second-line treatmentOther treatments when tumor response got PD | Procedure or surgery | Advanced group, Locally advanced group |
Primary outcome
OS
Time frame: From date of treatment beginning until the date of death from any cause, assessed up to 36 months.
The time from treatment initiation to death due to any cause
clinical complete response rate
Time frame: From date of treatment beginning until the date of first documented progression disease, up to 36 months.
The proportion of participants in the analysis population who have clinical complete response (CR) determined by investigators using mRECIST criteria at any time during the study.
3 secondary outcomes
PFS
Time frame: From date of treatment beginning until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months.
ORR
Time frame: From date of treatment beginning until the date of first documented progression disease, up to 36 months.
Number of patients with treatment-related adverse events
Time frame: From date of treatment beginning until the date of study treatment completion, up to 36 months.
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 8 May 2026.
- Individual participant dataSharing planned: Undecided
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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.
Xiaodong Wang study director
Peking University Cancer Hospital & Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HAIC(GOLF), Bevacizumab and PD-1/PD-L1 inhibitor in people with Biliary Tract Cancer (BTC), run by Peking University at 2 sites 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 7 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
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 Xiaodong Wang (0086-18611586227, xiaodongw75@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
OS (time frame: From date of treatment beginning until the date of death from any cause, assessed up to 36 months.). The study lists 2 primary outcomes in all. 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 8 May 2026.