Intrahepatic CholangiocarcinomaPhase 2NCT07841574
HAIC Plus QL1706 & Bevacizumab in Unresectable HER2-Negative ICC
A Phase 2 study testing hepatic arterial infusion chemotherapy (HAIC) combine with QL1706 and bevacizumab in people with Intrahepatic Cholangiocarcinoma, run by Lianghe Lu at 1 site in China.
Trial summary
Intrahepatic cholangiocarcinoma (ICC) has an increasing global incidence, and over 70% of patients are diagnosed at unresectable stages with limited survival benefits from standard first-line chemotherapy regimens. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Intrahepatic Cholangiocarcinoma
- What is being tested?
- hepatic arterial infusion chemotherapy (HAIC) combine with QL1706 and bevacizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteChina
- Study dates
- 11 Jun 2026to 30 Jun 2029
- Phase
- Phase 2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Age ≥18 years and ≤75 years. 2. Good general condition with Eastern Cooperative Oncology Group Performance Status (ECOG-PS) score of 0-1.
- 3. Histopathologically or cytopathologically confirmed intrahepatic cholangiocarcinoma (ICC).
- 4. No prior anti-tumor treatment for intrahepatic cholangiocarcinoma. 5. Confirmed as unresectable, non-ablatable and not eligible for other curative-intent therapies after multidisciplinary discussion by the hepatobiliary tumor expert team of this hospital.
- 6. Laboratory test results meet the following criteria (or achievable after short-term medical intervention):
- 1. Absolute neutrophil count ≥ 2.0 × 10⁹/L 2. Hemoglobin ≥ 100 g/L 3. Platelet count ≥ 75 × 10⁹/L 4. Plasma albumin ≥ 35 g/L 5. Total serum bilirubin < 2 × upper limit of normal (ULN) 6. Alanine aminotransferase (ALT) < 3 × ULN 7. Aspartate aminotransferase (AST) < 3 × ULN 8. Serum creatinine < 1.5 × ULN 9. Prothrombin time is normal or no more than 4 seconds above the ULN 10. International normalized ratio (INR) ≤ 2.2 7. Subjects fully understand the study and provide written informed consent. 8. Child-Pugh score ≤ 6 (Child-Pugh A class). 9. At least one measurable lesion per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
- 10. For women of child-bearing potential (including non-surgically sterilized subjects): use medically-accepted contraception during study treatment and for 3 months after completion of study treatment; serum or urine human chorionic gonadotropin (HCG) test must be negative within 72 hours prior to enrolment; must not be lactating. For male subjects with female partners of child-bearing potential: effective contraception is required during the study and for 3 months after the last dose of iparomlimab-tuvonralimab.
- 11. Expected survival ≥ 12 weeks. 12. No history of autoimmune diseases.
Who cannot join
- 1. Severe impairment of major organs including heart, brain, lung or kidney; severe infection or other serious comorbidities (CTCAE v5.0 adverse events ≥ Grade 2) rendering the subject intolerant to study treatment.
- 2. History of other malignant neoplasms. 3. History of allergic reactions to relevant study drugs. 4. Known hypersensitivity to any component of iparomlimab-tuvonralimab or to other monoclonal antibody agents.
- 5. History of solid-organ transplantation. 6. Prior anti-tumor therapy (including interferon) for ICC. 7. Human immunodeficiency virus (HIV) infection. 8. History of drug abuse or illicit-drug use. 9. Gastrointestinal hemorrhage or cardiovascular/cerebrovascular events within 30 days prior to enrolment.
- 10. Pregnant or lactating women; women of child-bearing potential unwilling to adopt contraceptive measures.
- 11. Psychiatric disorders that preclude informed consent or proper study participation.
- 12. Brain metastases, or bone metastases requiring urgent surgical or radiotherapy intervention.
Show all 15Show fewer
- 13. Active autoimmune disease or relevant medical history (including but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism). Note: Subjects with vitiligo; subjects with childhood-onset asthma fully resolved without intervention in adulthood may be enrolled; subjects requiring bronchodilators for asthma are excluded.
- 14. Receiving immunosuppressive agents or systemic corticosteroids for immunosuppressive purposes (prednisone > 10 mg/day or equivalent), and still on such therapy within 2 weeks before enrolment.
- 15. Administration of live vaccines within 4 weeks prior to study drug initiation or planned live-vaccine administration during study participation.
- 16. Other conditions judged by the investigator to interfere with study conduct or subject safety, such as heavy alcohol consumption, substance abuse, severe comorbid illnesses, marked laboratory abnormalities, or family/social circumstances that may compromise subject safety or protocol compliance.
- 17. Clinically significant bleeding episodes or definite bleeding tendency within 3 months before enrolment, e.g. hemoptysis ≥ 2.5 mL, gastrointestinal bleeding, high-risk esophageal-gastric varices, bleeding peptic ulcer, vasculitis. Note: If baseline stool occult blood is positive, repeat testing is required. Persistently positive stool occult blood warrants gastroscopy; subjects with severe esophageal-gastric varices on gastroscopy are excluded. Subjects with gastroscopy performed within the prior 3 months to rule out varices are exempt from repeat gastroscopy.
- 18. Uncorrectable coagulopathy or marked hematologic abnormalities with clear bleeding tendency (e.g. hemophilia, coagulation disorders, severe thrombocytopenia).
- 19. ECOG-PS score ≥ 2. 20. Child-Pugh score ≥ 7 (Child-Pugh B or C class). 21. Evidence of hepatic decompensation, e.g. massive ascites, history of upper gastrointestinal bleeding due to esophageal-gastric varices within the past year, hepatic encephalopathy or bilirubin encephalopathy.
- 22. Uncontrolled hypertension despite antihypertensive medication (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg).
- 23. HER2-positive tumor status. 24. Any other conditions that, in the investigator's opinion, may interfere with subject enrolment or endpoint assessment.
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, 1 recruiting
- Recruiting
Sun Yat-sen university cancer center
Guangzhou, Guangdong, 510060
Lianghe Lu, Dr, +8620-87343114, lulh@sysucc.org.cn
About this study
Official title: Hepatic Arterial Infusion Chemotherapy Combined With Iparomlimab/Tuvonralimab (QL1706) and Bevacizumab in Patients With Unresectable HER2-Negative Intrahepatic Cholangiocarcinoma:A Prospective Phase II Study
Intrahepatic cholangiocarcinoma (ICC) has an increasing global incidence, and over 70% of patients are diagnosed at unresectable stages with limited survival benefits from standard first-line chemotherapy regimens. Hepatic arterial infusion chemotherapy (HAIC) delivers high-concentration local chemotherapy to liver tumors, while the PD-1/CTLA-4 dual antibody iparomlimab and tuvonralimab (QL1706) combined with bevacizumab can reshape the immunosuppressive tumor microenvironment and exert synergistic anti-tumor effects.The purpose of this study is to evaluate the efficacy and safety of HAIC-FOLFOX plus QL1706 and bevacizumab as first-line therapy for patients with unresectable HER2-negative intrahepatic cholangiocarcinoma.
- Conditions
- Intrahepatic Cholangiocarcinoma
- Being tested
- hepatic arterial infusion chemotherapy (HAIC) combine with QL1706 and bevacizumab
- Keywords
- Intrahepatic Cholangiocarcinoma, FOLOFX-HAIC, QL1706
- Medical subject headings
- Cholangiocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hepatic arterial infusion chemotherapy (HAIC) combine with QL1706 and bevacizumabDrug
Also called HAIC, QL1706, Bevacizumab
Eligible patients were treated with HAIC plus QL1706 and bevacizumab. On the treatment day, continuous hepatic artery chemotherapy infusion was administered via an indwelling catheter connected to a micro-infusion pump. The infusion regimen included oxaliplatin 130 mg/m² over 3 hours, leucovorin 400 mg/m² over 1.5 hours, 5-FU 400 mg/m² over 2 hours, and 5-FU 2400 mg/m² over 46 hours. The catheter was removed after infusion completion.
On the subsequent morning, patients received intravenous QL1706 (7.5 mg/kg) and bevacizumab (15 mg/kg), and were discharged after infusion. Treatment was repeated every 3-4 weeks for up to six cycles.
Patients with favorable responses received continuous systemic maintenance therapy. Maintenance treatment was continued until death, intolerable toxicity, or loss of clinical benefit, with therapeutic regimens adjusted according to individual clinical status.
| Study group | Role | What they receive |
|---|---|---|
| Hepatic Arterial Infusion Chemotherapy (HAIC) Combine QL1706 and bevacizumab | Experimental | Not described Receives: Drug: hepatic arterial infusion chemotherapy (HAIC) combine with QL1706 and bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
objective response rate，ORR
ORR was defined as the proportion of patients achieving best overall response of complete response (CR) or partial response (PR) per RECIST 1.1.
Measured: From first dose of study treatment until the earliest of progression, death, start of subsequent anti-tumor therapy, or data cutoff, assessed up to 24 months.
Secondary outcomes (4)
disease control rate, DCR
DCR was defined as the proportion of patients achieving a best overall response of complete response (CR), partial response (PR), or stable disease.
Measured: From first dose of study treatment until the earliest of progression, death, start of subsequent anti-tumor therapy, or data cutoff, assessed up to 24 months.
progression-free survival, PFS
PFS was defined as the time from randomization to first documented tumor progression per RECIST 1.1 or death from any cause, including death without prior disease progression. Patients without progression at data cutoff or lost to follow-up were censored at the date of last adequate tumor assessment.
Measured: From date of randomization until the date of first documented progression or death, assessed up to 24 months.
Overall survival, OS
OS was defined as the time from first dose of study treatment to death from any cause. Patients who were alive at data cutoff or lost to follow-up were censored at the date last known to be alive.
Measured: From date of first study treatment until death from any cause, assessed up to 36 months.
Safety evaluation
Treatment-related adverse events were assessed according to the CTCAE 5.0 criteria.
Measured: From the date of first study treatment until 90 days after the last dose of study treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2026
- Study start11 Jun 2026
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intrahepatic CholangiocarcinomaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lianghe Lu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lianghe Lu, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07841574
- Sponsor's protocol ID
- SL-B2026-248-01
- Status last verified
- Sep 2026
- First submitted
- 21 Sep 2026
- Last updated
- 25 Sep 2026
- Results posted
- 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 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hepatic Arterial Infusion Chemotherapy Combined With Iparomlimab/Tuvonralimab (QL1706) and Bevacizumab in Patients With Unresectable HER2-Negative Intrahepatic Cholangiocarcinoma:A Prospective Phase II Study
- ClinicalTrials.gov ID
- NCT07841574
- Acronym / sponsor ID
- SL-B2026-248-01
- Conditions
- Intrahepatic Cholangiocarcinoma
- Keywords
- Intrahepatic Cholangiocarcinoma, FOLOFX-HAIC, QL1706
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Lianghe LuUniversity, hospital or other
- Study start
- 11 Jun 2026 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 25 Sep 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.
Intrahepatic cholangiocarcinoma (ICC) has an increasing global incidence, and over 70% of patients are diagnosed at unresectable stages with limited survival benefits from standard first-line chemotherapy regimens. Hepatic arterial infusion chemotherapy (HAIC) delivers high-concentration local chemotherapy to liver tumors, while the PD-1/CTLA-4 dual antibody iparomlimab and tuvonralimab (QL1706) combined with bevacizumab can reshape the immunosuppressive tumor microenvironment and exert synergistic anti-tumor effects.The purpose of this study is to evaluate the efficacy and safety of HAIC-FOLFOX plus QL1706 and bevacizumab as first-line therapy for patients with unresectable HER2-negative intrahepatic cholangiocarcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hepatic Arterial Infusion Chemotherapy (HAIC) Combine QL1706 and bevacizumab | Experimental | Drug: hepatic arterial infusion chemotherapy (HAIC) combine with QL1706 and bevacizumab |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 1. Age ≥18 years and ≤75 years. 2. Good general condition with Eastern Cooperative Oncology Group Performance Status (ECOG-PS) score of 0-1.
- 3. Histopathologically or cytopathologically confirmed intrahepatic cholangiocarcinoma (ICC).
- 4. No prior anti-tumor treatment for intrahepatic cholangiocarcinoma. 5. Confirmed as unresectable, non-ablatable and not eligible for other curative-intent therapies after multidisciplinary discussion by the hepatobiliary tumor expert team of this hospital.
- 6. Laboratory test results meet the following criteria (or achievable after short-term medical intervention):
- 1. Absolute neutrophil count ≥ 2.0 × 10⁹/L 2. Hemoglobin ≥ 100 g/L 3. Platelet count ≥ 75 × 10⁹/L 4. Plasma albumin ≥ 35 g/L 5. Total serum bilirubin < 2 × upper limit of normal (ULN) 6. Alanine aminotransferase (ALT) < 3 × ULN 7. Aspartate aminotransferase (AST) < 3 × ULN 8. Serum creatinine < 1.5 × ULN 9. Prothrombin time is normal or no more than 4 seconds above the ULN 10. International normalized ratio (INR) ≤ 2.2 7. Subjects fully understand the study and provide written informed consent. 8. Child-Pugh score ≤ 6 (Child-Pugh A class). 9. At least one measurable lesion per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
Key exclusion criteria (15 listed)
- 1. Severe impairment of major organs including heart, brain, lung or kidney; severe infection or other serious comorbidities (CTCAE v5.0 adverse events ≥ Grade 2) rendering the subject intolerant to study treatment.
- 2. History of other malignant neoplasms. 3. History of allergic reactions to relevant study drugs. 4. Known hypersensitivity to any component of iparomlimab-tuvonralimab or to other monoclonal antibody agents.
- 5. History of solid-organ transplantation. 6. Prior anti-tumor therapy (including interferon) for ICC. 7. Human immunodeficiency virus (HIV) infection. 8. History of drug abuse or illicit-drug use. 9. Gastrointestinal hemorrhage or cardiovascular/cerebrovascular events within 30 days prior to enrolment.
- 10. Pregnant or lactating women; women of child-bearing potential unwilling to adopt contraceptive measures.
- 11. Psychiatric disorders that preclude informed consent or proper study participation.
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 |
|---|---|---|
| hepatic arterial infusion chemotherapy (HAIC) combine with QL1706 and bevacizumabAlso: HAIC, QL1706, BevacizumabEligible patients were treated with HAIC plus QL1706 and bevacizumab. On the treatment day, continuous hepatic artery chemotherapy infusion was administered via an indwelling catheter connected to a micro-infusion pump. The infusion regimen included oxaliplatin 130 mg/m² over 3 hours, leucovorin 400 mg/m² over 1.5 hours, 5-FU 400 mg/m² over 2 hours, and 5-FU 2400 mg/m² over 46 hours. The catheter was removed after infusion completion. On the subsequent morning, patients received intravenous QL1706 (7.5 mg/kg) and bevacizumab (15 mg/kg), and were discharged after infusion. Treatment was repeated every 3-4 weeks for up to six cycles. Patients with favorable responses received continuous systemic maintenance therapy. Maintenance treatment was continued until death, intolerable toxicity, or loss of clinical benefit, with therapeutic regimens adjusted according to individual clinical status. | Drug | Hepatic Arterial Infusion Chemotherapy (HAIC) Combine QL1706 and bevacizumab |
Primary outcome
objective response rate，ORR
Time frame: From first dose of study treatment until the earliest of progression, death, start of subsequent anti-tumor therapy, or data cutoff, assessed up to 24 months.
ORR was defined as the proportion of patients achieving best overall response of complete response (CR) or partial response (PR) per RECIST 1.1.
4 secondary outcomes
disease control rate, DCR
Time frame: From first dose of study treatment until the earliest of progression, death, start of subsequent anti-tumor therapy, or data cutoff, assessed up to 24 months.
progression-free survival, PFS
Time frame: From date of randomization until the date of first documented progression or death, assessed up to 24 months.
Overall survival, OS
Time frame: From date of first study treatment until death from any cause, assessed up to 36 months.
Safety evaluation
Time frame: From the date of first study treatment until 90 days after the last dose of study treatment.
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 25 Sep 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 2 study testing hepatic arterial infusion chemotherapy (HAIC) combine with QL1706 and bevacizumab in people with Intrahepatic Cholangiocarcinoma, run by Lianghe Lu 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 7 inclusion and 15 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 25 Sep 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Rongping Guo, Pro. (+86 20 8734 2266, guorp@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
objective response rate，ORR (time frame: From first dose of study treatment until the earliest of progression, death, start of subsequent anti-tumor therapy, or data cutoff, assessed up to 24 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 25 Sep 2026.