Intrahepatic CholangiocarcinomaPhase 2NCT06208462
Neoadjuvant Therapy of HAIC（GEMOX） Combined With Adebrelimab and Lenvatinib for Resectable Intrahepatic Cholangiocarcinoma With High-risk Recurrence Factors
A Phase 2 study testing Adebrelimab, Lenvatinib and Gemcitabine in people with Intrahepatic Cholangiocarcinoma, run by The First Affiliated Hospital with Nanjing Medical University at 3 sites in China.
Trial summary
Clinical Study on the efficacy and safety of HAIC（GEMOX）and Lenvatinib combined with Adebrelimab neoadjuvant therapy for resectable Intrahepatic Cholangiocarcinoma with high-risk recurrence factors. 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?
- Adebrelimab, Lenvatinib and Gemcitabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 3 sitesChina
- Study dates
- 19 Jan 2024to Jan 2027
- 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
- The patient must sign the informed consent;
- Age 18-75 years old, male and female;
- ECOG Physical status Score (PS score) 0 or 1;
- Patients with ICC who have been pathologically diagnosed (histopathological and/or cytological examination) or clinically diagnosed as having high-risk factors;
- Risk factors are defined as follows:
- Stage ≥Ib, single lesion > 5cm, multiple tumor lesions in the same lobe, technically resectable;Vascular invasion, regional lymph node metastasis, technically resectable
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- Patients with untreated and resectable locally advanced ICC who have been assessed by the surgeon as surgically resectable;
- The functional indicators of vital organs meet the following requirements
- ① Neutrophils ≥1.5109/L; Platelet ≥80109/L; Hemoglobin ≥9g/dl; Serum albumin ≥3g/dl;② Thyroid stimulating hormone (TSH) ≤ 1 times the upper limit of normal, T3, T4 in the normal range;③ Bilirubin ≤ 1.5 times the upper limit of normal value; ALT and AST≤ 2 times the upper limit of normal value;④ Serum creatinine ≤ 1.5 times the upper limit of normal value, creatinine clearance ≥60 ml/min;
- The subject has at least one measurable lesion (according to RECIST1.1);
- Fertile women: must agree to abstain from sex (abstain from heterosexual intercourse) or use a reliable, effective method of contraception for at least 120 days from the signing of the informed consent until the final administration of the study drug. Serum HCG test must be negative within 72 hours before randomization. And must be non-lactating.A woman is considered fertile if she has menstruated, has not yet reached postmenopausal status (no continuous periods for ≥12 months, no cause other than menopause has been found), and has not undergone sterilization (such as hysterectomy, bilateral tubal ligation, or bilateral oophorectomy).
- For male subjects whose partner is a fertile woman, they must agree to abstain from sex or use a reliable, effective method of contraception for at least 120 days from the signing of the informed consent until the final administration of the study drug. Male subjects also had to agree not to donate sperm during the same time period. Male subjects with a pregnant partner are required to use condoms and do not need to use other methods of contraception.
Who cannot join
- Pathological diagnosis of hepatocellular carcinoma, mixed hepatocellular carcinoma and other non-cholangiocarcinoma malignant tumor components;
- Prior systemic therapy and tumor-related surgical treatment (biliary drainage allowed);Patients who relapse after surgery, have received PD1 antibody, PDL1 antibody or CTLA4 antibody, Lenvatinib, chemotherapy in the past; participated in other clinical trials 30 days before screening
- Previous or co-existing malignancies other than adequately treated non-melanin skin cancer, cervical carcinoma in situ and thyroid papillary carcinoma;
- Active pulmonary tuberculosis infection. Patients with active pulmonary tuberculosis infection within 1 year prior to enrollment; Had a history of active tuberculosis infection more than 1 year before enrollment, had not received formal anti-tuberculosis therapy or had active tuberculosis;
- Have an active, known, or suspected autoimmune disease. Subjects with hypothyroidism requiring hormone replacement therapy and skin conditions that do not require systemic therapy are eligible;
- Long-term acceptance of systemic sex hormones (doses equivalent to \> 10mg prednisone per day) or any other form of immunosuppressive therapy. Participants using inhaled or topical corticosteroids may be enrolled;
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- Severe cardiopulmonary and renal dysfunction;
- Have hypertension that is not well controlled by antihypertensive medication (systolic blood pressure ≥140mmHg or diastolic blood pressure ≥90mmHg);
- Abnormal coagulation function (PT\> 14s), have a tendency to bleed or are receiving thrombolytic or anticoagulant therapy;
- HBV DNA\> 2000IU/ml, HCV RNA\> 1000 IU/ml;
- Had clinically significant bleeding symptoms or a clear tendency to appear within 3 months before enrollment;
- Active infections that require systemic treatment;
- Human immunodeficiency virus (HIV, HIV1/2 antibodies) positive;
- Have a history of psychotropic substance abuse, alcohol abuse or drug use;
- Have a history of drug allergy;
- Other factors, as determined by the investigator, that may affect the subject's safety or compliance with the test. Such as a serious illness (including mental illness) requiring co-treatment, serious laboratory abnormalities, or other family or social factors.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites, 3 recruiting
- Recruiting
West China Hospital
Chengdu, Sichuan, 610000
Wentao Wang, +86 189 8060 1895, wwtdoctor02@163.com
- Recruiting
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu
Feng Cheng
- Recruiting
Ningbo Medical Center Lihuili Hospital
Ningbo, Zhejiang, 315000
Jing Huang, +8613819803591, huangjingonline@163.com
About this study
Official title: Neoadjuvant Therapy of HAIC（GEMOX） Combined With Adebrelimab and Lenvatinib for Resectable Intrahepatic Cholangiocarcinoma With High-risk Recurrence Factors：NEO-ERA-01 Study
Clinical Study on the efficacy and safety of HAIC（GEMOX）and Lenvatinib combined with Adebrelimab neoadjuvant therapy for resectable Intrahepatic Cholangiocarcinoma with high-risk recurrence factors.
Read the detailed description
Intrahepatic cholangiocarcinoma (ICC) accounts for more than 20% of hepatic malignancies and has become the second most common primary liver tumor worldwide. The incidence of ICC is increasing annually, showing a trend to affecting younger individuals. Treatment options for ICC contain surgical resection, perioperative chemotherapy, liver-directed therapies and systemic therapy such as cytotoxic therapy, targeted therapy and immunotherapy. Adjuvant chemotherapy after ICC resection has become the standard for patients with resected ICC based on the BILCAP trial with better mOS (53 months vs. 36 months, p=0.028) and RFS (25.9 months vs. 17.4 months, p=0.0093). The rationale for neoadjuvant chemotherapy for patients with resectable ICC also suggests a potential advantage according to NEO-GAP. While the effectiveness of hepatic artery infusion chemotherapy (HAIC) has been proven in unresectable ICC, its role in resectable ICC is controversial. The TOPAZ-1 trial demonstrated the efficacy of immune checkpoint blockade in ICC. However, it remains to be seen whether combined therapy above is effective in resectable ICC.
Surgical resection remains the mainstay for ICC therapy, but postoperative patients often have a high tumor recurrence rate. The median time of disease-free survival is 18.5 months, and recurrence rate is 60%-65%. Previous research suggests that the prognosis of ICC depends on several risk factors for recurrence consisting of Stage ≥ Ib (AJCC 8th), tumor size > 5cm, multiple tumor lesions in the same lobe, presence of radiographic major vascular invasion, or lymph node involvement, technically resectable. Further investigation is needed to evaluate the effectiveness of the comprehensive treatment system, which includes HAIC (GEMOX), immunotherapy, neoadjuvant therapy, and surgical resection, for ICC with high-risk recurrence factors.
The goal of this clinical trial is to assess the efficacy and safety of HAIC (GEMOX) and Lenvatinib combined with Adebrelimab neoadjuvant therapy for resectable ICC with high-risk recurrence factors. The primary end point is to evaluate the propotion of treatment completion (including neo-adjuvant therapy and surgery), and the second outcome measures include overall survival (OS), objective response rate (ORR), pathological complete response (pCR) and the recurrence free survival (RFS) of patients after treatment. In order to investigate more effective ICC therapies, participants will undergo 2-4 cycles of HAIC (GEMOX) in combination with Lenvatinib and Adebrelimab. Evaluation will be conducted every 2 cycles, and surgery will be performed when qualified. Capecitabine will be administered for 1-14 days after surgery, and regular follow-up will be conducted.
- Conditions
- Intrahepatic Cholangiocarcinoma
- Being tested
- Adebrelimab, Lenvatinib, Gemcitabine, Oxaliplatin
- Medical subject headings
- Cholangiocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdebrelimabDrug
Also called SHR-1316
1200mg，i.v. , q3w
LenvatinibDrug
Also called 4-{3-chloro-4-[(cyclopropylcarbamoyl)amino]phenoxy}-7-methoxyquinoline-6-carboxamide
8mg,qd
GemcitabineDrug
Also called Difluorodeoxycytidine Hydrochloride
800 mg/m2，q3w
OxaliplatinDrug
Also called Diaminocyclohexane Oxalatoplatinum
85 mg/m2，q3w
| Study group | Role | What they receive |
|---|---|---|
| Combined treatment group | Experimental | 1. Preoperative treatment 3 weeks is a course of treatment HAIC (GEMOX) chemotherapy
1. It is performed within one week after the identification of ICC
2. Day 1 HAIC (GEMOX) Oxaliplatin 85mg/m2 + Gemcitabine 800mg/m2 Adebrelimab: Day 3 Adebrelimab 1200mg i.v. Lenvatinib 2# qd
2. Evaluation every 2 courses, up to 4 courses.
3. Liver resection: It is performed within 1 month after preoperative treatment.
4. Postoperative treatment: Day 1-14 Capecitabine 1200mg B.I.D. Receives: Drug: Adebrelimab; Drug: Lenvatinib; Drug: Gemcitabine; Drug: Oxaliplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Propotion of treatment completion
Propotion of treatment completion (including neo-adjuvant therapy and surgery)
Measured: one year
Secondary outcomes (10)
Assess safety and tolerability
Assess safety and tolerability of HAIC（GEMOX）and Lenvatinib combined with Adebrelimab neoadjuvant therapy
Measured: one year
OS
Overall survival (OS)
Measured: one year
pCR
Pathological Complete Response (pCR)
Measured: one year
R0 resection rate
The percentage of patients received R0 resection after HAIC（GEMOX）and Lenvatinib combined with Adebrelimab neoadjuvant therapy
Measured: one year
Major pathological response (MPR)
Major pathological response (MPR) is defined as ≤50% residual viable tumor cells in the resection bed.
Measured: Until the surgery is over
PFS
Progression-free survival (PFS)
Measured: one year
Surgical rate
The surgical rate of patients after HAIC（GEMOX）and Lenvatinib combined with Adebrelimab neoadjuvant therapy
Measured: one year
ORR
Objective Response Rate （ORR）
Measured: one year
Event-free survival (EFS)
Event-free survival (EFS)
Measured: one year
Disease control rate (DCR)
disease control rate (DCR)
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2024
- Study start19 Jan 2024
- Primary completionJan 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intrahepatic CholangiocarcinomaStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe sponsor's other registered studies.
- 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
- 33 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangsu Hengrui Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Feng Cheng, MD, Study director, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06208462
- Sponsor's protocol ID
- NEO-ERA-01
- Status last verified
- Jan 2025
- First submitted
- 6 Jan 2024
- Last updated
- 3 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cheng Y, Xia J, Chi Y, Rao J, Cheng F; CLEAP China Liver Cancer Study Group Young Investigators (CLEAP). Neoadjuvant hepatic arterial infusion chemotherapy (HAIC) with GEMOX and lenvatinib in combination with adebrelimab for resectable high-risk recurrent intrahepatic cholangiocarcinoma (ICC): study protocol of the NEO-ERA-01 feasibility trial. BMJ Open. 2026 Feb 23;16(2):e101101. doi: 10.1136/bmjopen-2025-101101.
PubMed 41730557
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Therapy of HAIC（GEMOX） Combined With Adebrelimab and Lenvatinib for Resectable Intrahepatic Cholangiocarcinoma With High-risk Recurrence Factors：NEO-ERA-01 Study
- ClinicalTrials.gov ID
- NCT06208462
- Acronym / sponsor ID
- NEO-ERA-01
- Conditions
- Intrahepatic Cholangiocarcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Collaborators
- Jiangsu Hengrui Pharmaceutical Co., Ltd.
- Study start
- 19 Jan 2024 (actual)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 17 Jan 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.
Clinical Study on the efficacy and safety of HAIC（GEMOX）and Lenvatinib combined with Adebrelimab neoadjuvant therapy for resectable Intrahepatic Cholangiocarcinoma with high-risk recurrence factors.
Detailed description
Intrahepatic cholangiocarcinoma (ICC) accounts for more than 20% of hepatic malignancies and has become the second most common primary liver tumor worldwide. The incidence of ICC is increasing annually, showing a trend to affecting younger individuals. Treatment options for ICC contain surgical resection, perioperative chemotherapy, liver-directed therapies and systemic therapy such as cytotoxic therapy, targeted therapy and immunotherapy. Adjuvant chemotherapy after ICC resection has become the standard for patients with resected ICC based on the BILCAP trial with better mOS (53 months vs. 36 months, p=0.028) and RFS (25.9 months vs. 17.4 months, p=0.0093). The rationale for neoadjuvant chemotherapy for patients with resectable ICC also suggests a potential advantage according to NEO-GAP. While the effectiveness of hepatic artery infusion chemotherapy (HAIC) has been proven in unresectable ICC, its role in resectable ICC is controversial. The TOPAZ-1 trial demonstrated the efficacy of immune checkpoint blockade in ICC. However, it remains to be seen whether combined therapy above is effective in resectable ICC.
Surgical resection remains the mainstay for ICC therapy, but postoperative patients often have a high tumor recurrence rate. The median time of disease-free survival is 18.5 months, and recurrence rate is 60%-65%. Previous research suggests that the prognosis of ICC depends on several risk factors for recurrence consisting of Stage ≥ Ib (AJCC 8th), tumor size > 5cm, multiple tumor lesions in the same lobe, presence of radiographic major vascular invasion, or lymph node involvement, technically resectable. Further investigation is needed to evaluate the effectiveness of the comprehensive treatment system, which includes HAIC (GEMOX), immunotherapy, neoadjuvant therapy, and surgical resection, for ICC with high-risk recurrence factors.
The goal of this clinical trial is to assess the efficacy and safety of HAIC (GEMOX) and Lenvatinib combined with Adebrelimab neoadjuvant therapy for resectable ICC with high-risk recurrence factors. The primary end point is to evaluate the propotion of treatment completion (including neo-adjuvant therapy and surgery), and the second outcome measures include overall survival (OS), objective response rate (ORR), pathological complete response (pCR) and the recurrence free survival (RFS) of patients after treatment. In order to investigate more effective ICC therapies, participants will undergo 2-4 cycles of HAIC (GEMOX) in combination with Lenvatinib and Adebrelimab. Evaluation will be conducted every 2 cycles, and surgery will be performed when qualified. Capecitabine will be administered for 1-14 days after surgery, and regular follow-up will be conducted.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Combined treatment group | Experimental | Drug: Adebrelimab, Drug: Lenvatinib, Drug: Gemcitabine, Drug: Oxaliplatin1. Preoperative treatment 3 weeks is a course of treatment HAIC (GEMOX) chemotherapy 1. It is performed within one week after the identification of ICC 2. Day 1 HAIC (GEMOX) Oxaliplatin 85mg/m2 + Gemcitabine 800mg/m2 Adebrelimab: Day 3 Adebrelimab 1200mg i.v. Lenvatinib 2# qd 2. Evaluation every 2 courses, up to 4 courses. 3. Liver resection: It is performed within 1 month after preoperative treatment. 4. Postoperative treatment: Day 1-14 Capecitabine 1200mg B.I.D. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- The patient must sign the informed consent;
- Age 18-75 years old, male and female;
- ECOG Physical status Score (PS score) 0 or 1;
- Patients with ICC who have been pathologically diagnosed (histopathological and/or cytological examination) or clinically diagnosed as having high-risk factors;
- Stage ≥Ib, single lesion > 5cm, multiple tumor lesions in the same lobe, technically resectable;Vascular invasion, regional lymph node metastasis, technically resectable
Key exclusion criteria (16 listed)
- Pathological diagnosis of hepatocellular carcinoma, mixed hepatocellular carcinoma and other non-cholangiocarcinoma malignant tumor components;
- Prior systemic therapy and tumor-related surgical treatment (biliary drainage allowed);Patients who relapse after surgery, have received PD1 antibody, PDL1 antibody or CTLA4 antibody, Lenvatinib, chemotherapy in the past; participated in other clinical trials 30 days before screening
- Previous or co-existing malignancies other than adequately treated non-melanin skin cancer, cervical carcinoma in situ and thyroid papillary carcinoma;
- Active pulmonary tuberculosis infection. Patients with active pulmonary tuberculosis infection within 1 year prior to enrollment; Had a history of active tuberculosis infection more than 1 year before enrollment, had not received formal anti-tuberculosis therapy or had active tuberculosis;
- Have an active, known, or suspected autoimmune disease. Subjects with hypothyroidism requiring hormone replacement therapy and skin conditions that do not require systemic therapy are eligible;
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 |
|---|---|---|
| AdebrelimabAlso: SHR-13161200mg，i.v. , q3w | Drug | Combined treatment group |
| LenvatinibAlso: 4-{3-chloro-4-[(cyclopropylcarbamoyl)amino]phenoxy}-7-methoxyquinoline-6-carboxamide8mg,qd | Drug | Combined treatment group |
| GemcitabineAlso: Difluorodeoxycytidine Hydrochloride800 mg/m2，q3w | Drug | Combined treatment group |
| OxaliplatinAlso: Diaminocyclohexane Oxalatoplatinum85 mg/m2，q3w | Drug | Combined treatment group |
Primary outcome
Propotion of treatment completion
Time frame: one year
Propotion of treatment completion (including neo-adjuvant therapy and surgery)
10 secondary outcomes
Assess safety and tolerability
Time frame: one year
OS
Time frame: one year
pCR
Time frame: one year
R0 resection rate
Time frame: one year
Major pathological response (MPR)
Time frame: Until the surgery is over
PFS
Time frame: one year
Surgical rate
Time frame: one year
ORR
Time frame: one year
Event-free survival (EFS)
Time frame: one year
Disease control rate (DCR)
Time frame: one year
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 3 Mar 2025.
- Derived from this study: PubMed 41730557Cheng Y, Xia J, Chi Y, Rao J, Cheng F; CLEAP China Liver Cancer Study Group Young Investigators (CLEAP). Neoadjuvant hepatic arterial infusion chemotherapy (HAIC) with GEMOX and lenvatinib in combination with adebrelimab for resectable high-risk recurrent intrahepatic cholangiocarcinoma (ICC): study protocol of the NEO-ERA-01 feasibility trial. BMJ Open. 2026 Feb 23;16(2):e101101. doi: 10.1136/bmjopen-2025-101101.
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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.
Feng Cheng, MD study director
The First Affiliated Hospital with Nanjing Medical University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Adebrelimab, Lenvatinib and Gemcitabine in people with Intrahepatic Cholangiocarcinoma, run by The First Affiliated Hospital with Nanjing Medical University at 3 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 12 inclusion and 16 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 3 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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.
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 Feng Cheng, MD (13305170695, docchengfeng@njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Propotion of treatment completion (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06208462, which also lists 1 linked publication.
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 3 Mar 2025.