Intrahepatic CholangiocarcinomaNCT06643208
D-TACE-HAIC Combined With Envafolimab and Lenvatinib for Unresectable ICC
An observational study of Intrahepatic Cholangiocarcinoma, run by Fujian Provincial Hospital at 1 site in China.
Trial summary
This is a prospective, single-arm, multicenter, phase II trial to evaluate the efficacy and safety of D-TACE-HAIC (GEMOX protocol) in combination with Envafolimab and Lenvatinib for unresectable intrahepatic cholangiocarcinoma. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Intrahepatic Cholangiocarcinoma
- What is being tested?
- TACE-HAIC, Envafolimab and Lenvatinib
- How many people
- 37 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2024to 1 Mar 2027
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients diagnosed with unresectable intrahepatic cholangiocarcinoma
Who may be able to join
- 1. Ages of 18 and 75;
- 2. Child-Pugh liver function grade: A/B;
- 3. ECOG score (see annex for scoring standards) : ≤1 score;
- 4. ICC was confirmed by pathology and evaluated by two senior hepatobiliary surgeons as unresectable for surgery (including multiple intrahepatic lesions, local vascular invasion, local lymph node metastasis, and distant metastasis);
- 5. According to RECIST 1.1 criteria, the patient has at least one measurable lesion (the CT/MRI scan diameter of the lesion can be measured ≥10mm, and the lesion has not received local treatment such as radiotherapy or freezing);
- 6. The expected survival time is greater than 3 months;
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- 7. Patients who had not received any tumor-related targeting, immunization, radiotherapy or chemotherapy before enrollment;
- 8. Functional indexes of vital organs met the following requirements: · Routine blood: absolute neutrophil count ≥1.5×109/L, Hb≥9.0g/L, PLT≥75×109/L; · Liver function: total bilirubin ≤1.5 times the upper limit of normal (ULN) (≤2.5 times ULN after biliary drainage in patients with obstructive jaundice); Alanine aminotransferase (ALT), aspartate aminotransferase (AST)≤ 5x ULN, albumin ≥30g /L; · Renal function: serum creatinine ≤1.5mg/dL, creatinine clearance ≥60ml /min; · Coagulation function: International standardized ratio (INR) and activated partial thromboplastin time (APTT)≤1.5 times ULN;
- 9. No history of severe arrhythmia or heart failure; No history of severe ventilation dysfunction or severe pulmonary infection;
- 10. Women of childbearing age should agree to use contraception during the use of medication and for 6 months after the end of medication; Patients who had a negative serum or urine pregnancy test in the 7 days prior to study enrollment and must be non-lactating patients, men should consent to use contraception during the study period and for 6 months after the end of the study period.
Who cannot join
- 1. Patients who have previously received other local anti-tumor treatments (such as radiotherapy, radiofrequency ablation, etc.), who are allowed to relapse 6 months after previous surgery, and who are allowed to undergo biliary drainage (including PTCD and biliary stent implantation);
- 2. History of allergy to gemcitabine, oxaliplatin, Envolizumab, Renvastinib and its components;
- 3. A history of other malignant tumors within the past 5 years or at the same time, except cured basal cell carcinoma of the skin, cervical carcinoma in situ and thyroid papillary carcinoma;
- 4. Patients who have previously received an organ transplant or are planning to receive an organ transplant;
- 5. The presence of any active autoimmune disease or patients with autoimmune disease and expected recurrence (such as interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these diseases and syndromes);
- 6. History of immune deficiency; The patient is taking immunosuppressants or systemic hormone therapy for immunosuppressive purposes and continues to use it within 2 weeks prior to signing the informed consent;
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- 7. Known hereditary or acquired bleeding (e.g. coagulation disorders) or thrombotic tendencies, e.g. in hemophiliacs; Is currently or recently (within 10 days prior to the start of study therapy) used full dose oral or injectable anticoagulants or thrombolytic agents for therapeutic purposes (prophylactic use of low-dose aspirin, low-molecular weight heparin permitted);
- 8. Serious infections, such as severe pneumonia, bacteremia, and comorbiditis requiring hospitalization, occurred within 4 weeks prior to the first use of the study drug; Baseline chest imaging findings indicate active lung inflammation, signs and symptoms of infection within 2 weeks prior to the first use of the study drug, or the need for oral or intravenous antibiotic treatment (excluding prophylactic antibiotic use);
- 9. Patients with mental illness; Have a history of psychotropic substance abuse, alcoholism and drug use;
- 10. Pregnant or lactating women;
- 11. Those who, according to the judgment of the researcher, should not participate in this experiment for other reasons;
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
Fujian Provincial Hospital
Fuzhou, Fujian
Mao-Lin Yan, 0591-88217140, yanmaolin74@163.com
About this study
Official title: Department of Hepatobiliary Pancreatic Surgery, Fujian Provincial Hospital
This is a prospective, single-arm, multicenter, phase II trial to evaluate the efficacy and safety of D-TACE-HAIC (GEMOX protocol) in combination with Envafolimab and Lenvatinib for unresectable intrahepatic cholangiocarcinoma.
- Conditions
- Intrahepatic Cholangiocarcinoma
- Being tested
- TACE-HAIC, Envafolimab and Lenvatinib
- Medical subject headings
- Cholangiocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TACE-HAIC, Envafolimab and LenvatinibDrug
TACE-HAIC (GEMOX regimen) combined with Envafolimab and Lenvatinib
| Study group | Role | What they receive |
|---|---|---|
| Combination therapy group | Patients with unresectable cholangiocarcinoma were treated with D-TACE-HAIC (GEMOX regimen) combined with envafolimab and lenvatinib Receives: Drug: TACE-HAIC, Envafolimab and Lenvatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate, ORR
The Objective response rate (ORR) was defined as the complete response (CR) rate or the partial response (PR) rate according to RECIST v1.1 criteria.
Measured: Four weeks after the initiation of medication
Secondary outcomes (4)
Overall survival, OS
The Overall survival (OS) was defined as the time between receiving treatment and observing death or loss of follow-up for any reason.
Measured: From date of enrollment until the date of death from any cause, assessed up to 60 months
Progression-free survival, PFS
The Progression free survival (PFS) was defined as the time between the start of treatment and the progression of intrahepatic and/or extrahepatic tumors, or the occurrence of death or loss of follow-up for any reason.
Measured: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
Disease control rate, DCR
The Disease control rate (DCR) was defined as the complete response (CR) rate or the partial response (PR) rate or stable disease (SD) rate according to RECIST v1.1 criteria.
Measured: Four weeks after the initiation of medication
Treatment-related adverse events, TRAEs treatment-related adverse events
The incidence, spectrum and severity of adverse events (AE) and serious adverse events (SAE) were determined according to the NCI-CTCAE V5.0 standard. Dose suspension rate and dose termination rate due to adverse events.
Measured: From the initiation of medication, with recordings made whenever an adverse reaction occurs, assessed up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2024
- Study start1 Jul 2024
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Mar 2027 (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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 37 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Provincial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mao-Lin Yan, Fujian Provincial Hospital
- Investigators
- Maolin Yan, Doctor, Study chair, Department of Hepatobiliary Pancreatic Surgery, Fujian Provincial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06643208
- Sponsor's protocol ID
- TALENP005
- Status last verified
- Jun 2025
- First submitted
- 13 Oct 2024
- Last updated
- 26 Jun 2025
- 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 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Department of Hepatobiliary Pancreatic Surgery, Fujian Provincial Hospital
- ClinicalTrials.gov ID
- NCT06643208
- Acronym / sponsor ID
- TALENP005
- Conditions
- Intrahepatic Cholangiocarcinoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 37 participants (estimated)
- Lead sponsor
- Fujian Provincial HospitalUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 16 Oct 2024 (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, single-arm, multicenter, phase II trial to evaluate the efficacy and safety of D-TACE-HAIC (GEMOX protocol) in combination with Envafolimab and Lenvatinib for unresectable intrahepatic cholangiocarcinoma.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Combination therapy group | – | Drug: TACE-HAIC, Envafolimab and LenvatinibPatients with unresectable cholangiocarcinoma were treated with D-TACE-HAIC (GEMOX regimen) combined with envafolimab and lenvatinib |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with unresectable intrahepatic cholangiocarcinoma
Key inclusion criteria (10 listed)
- 1. Ages of 18 and 75;
- 2. Child-Pugh liver function grade: A/B;
- 3. ECOG score (see annex for scoring standards) : ≤1 score;
- 4. ICC was confirmed by pathology and evaluated by two senior hepatobiliary surgeons as unresectable for surgery (including multiple intrahepatic lesions, local vascular invasion, local lymph node metastasis, and distant metastasis);
- 5. According to RECIST 1.1 criteria, the patient has at least one measurable lesion (the CT/MRI scan diameter of the lesion can be measured ≥10mm, and the lesion has not received local treatment such as radiotherapy or freezing);
Key exclusion criteria (11 listed)
- 1. Patients who have previously received other local anti-tumor treatments (such as radiotherapy, radiofrequency ablation, etc.), who are allowed to relapse 6 months after previous surgery, and who are allowed to undergo biliary drainage (including PTCD and biliary stent implantation);
- 2. History of allergy to gemcitabine, oxaliplatin, Envolizumab, Renvastinib and its components;
- 3. A history of other malignant tumors within the past 5 years or at the same time, except cured basal cell carcinoma of the skin, cervical carcinoma in situ and thyroid papillary carcinoma;
- 4. Patients who have previously received an organ transplant or are planning to receive an organ transplant;
- 5. The presence of any active autoimmune disease or patients with autoimmune disease and expected recurrence (such as interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these diseases and syndromes);
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 |
|---|---|---|
| TACE-HAIC, Envafolimab and LenvatinibTACE-HAIC (GEMOX regimen) combined with Envafolimab and Lenvatinib | Drug | Combination therapy group |
Primary outcome
Objective response rate, ORR
Time frame: Four weeks after the initiation of medication
The Objective response rate (ORR) was defined as the complete response (CR) rate or the partial response (PR) rate according to RECIST v1.1 criteria.
4 secondary outcomes
Overall survival, OS
Time frame: From date of enrollment until the date of death from any cause, assessed up to 60 months
Progression-free survival, PFS
Time frame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
Disease control rate, DCR
Time frame: Four weeks after the initiation of medication
Treatment-related adverse events, TRAEs treatment-related adverse events
Time frame: From the initiation of medication, with recordings made whenever an adverse reaction occurs, assessed up to 12 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 26 Jun 2025.
- 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.
Maolin Yan, Doctor study chair
Department of Hepatobiliary Pancreatic Surgery, Fujian Provincial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intrahepatic Cholangiocarcinoma, run by Fujian Provincial Hospital 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 10 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: looking for participants now, as of the sponsor's last update on 26 Jun 2025. 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.
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 Maolin Yan, Doctor (15960066307, yanmaolin74@163.com), 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: Four weeks after the initiation of medication). 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 26 Jun 2025.