Locally Advanced Perihilar CholangiocarcinomaPhase 2ACHIEVE-LTNCT07471165
A Prospective, Single-Arm, Phase II Study: PD-L1 Monoclonal Antibody + Chemoradiotherapy as Bridge Therapy to Liver Transplantation for Locally Advanced Perihilar Cholangiocarcinoma (ACHIEVE-LT)
A Phase 2 study testing PD -1/PD-L1 monoclonal antibody plus radiotherapy and liver transplantation in people with Locally Advanced Perihilar Cholangiocarcinoma, run by The First Affiliated Hospital with Nanjing Medical University at 2 sites in China.
Trial summary
This study is a prospective, single-arm, phase II clinical trial designed to evaluate the safety and efficacy of PD-L1 monoclonal antibody combined with chemoradiotherapy as a bridge to liver transplantation in patients with locally advanced unresectable perihilar cholangiocarcinoma (pCCA). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Locally Advanced Perihilar Cholangiocarcinoma
- What is being tested?
- PD -1/PD-L1 monoclonal antibody plus radiotherapy and liver transplantation
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 2 sitesChina
- Study dates
- 1 Mar 2026to 1 Jul 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient voluntarily participates in this study and signs an informed consent form.
- The patient is aged between 18 and 70 years old.
- The patient has pathologically confirmed locally advanced perihilar cholangiocarcinoma (pCCA) without concurrent lymph node or distant metastasis, and meets at least one of the following criteria:
- Bile duct invasion: involvement of bilateral secondary bile ducts.
- Portal vein invasion: involvement of unilateral or bilateral branches and the main trunk.
- Hepatic artery invasion: involvement of unilateral or bilateral branches.
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- Liver invasion: involvement of liver parenchyma or insufficient residual liver volume.
- The patient has at least one measurable lesion (as per RECIST 1.1 criteria). The patient has an ECOG performance status score of 0 to 1. The patient has not received any prior systemic or local therapy.
- The patient has adequate organ and bone marrow function, and laboratory test results meet the following requirements:
- Hemoglobin ≥ 90 g/L.
- Absolute neutrophil count ≥ 1.5 × 10^9/L.
- Platelet count ≥ 100 × 10^9/L.
- Liver function classified as Child-Pugh A, with total bilirubin ≤ 3 times the upper limit of normal (ULN).
- ALT and AST ≤ 3 times ULN; for patients with obstructive jaundice, if liver function indicators meet the inclusion criteria after treatment with PTCD or ERCP, they may be considered for inclusion.
- Serum creatinine ≤ 1.5 times ULN; endogenous creatinine clearance rate ≥ 50 ml/min (Cockcroft-Gault formula).
- Urine protein < (++), or 24-hour urine protein < 1.0 g.
- The patient has normal coagulation function and no active bleeding:
- International normalized ratio (INR) ≤ 1.5.
- Activated partial thromboplastin time (APTT) ≤ 1.5 times ULN.
- If the subject has HBV or HCV infection, the following conditions must be met:
- For inactive/asymptomatic HBV carriers or chronic/active HBV carriers: HBV deoxyribonucleic acid (DNA) < 2000 copies/mL during screening. (Note: Patients with HBV DNA > 2000 copies/mL should be treated according to treatment guidelines. Patients receiving antiviral therapy at the time of screening should have HBV-DNA < 2000 copies/mL and continue treatment during the study.)
- For subjects infected with HCV: if infection is confirmed by detectable HCV ribonucleic acid (RNA), such subjects cannot be included in the group.
- No pregnancy or plans for pregnancy: If you are a woman of childbearing potential (i.e., physically capable of becoming pregnant), you must agree to use effective contraception during the study and for 120 days after the last dose, and have a negative urine or serum pregnancy test within 7 days before the first dose. If you are a non-sterilized male, you need to agree to use effective contraception during the study and for 120 days after the last dose.
- -
Who cannot join
- Diagnosed with intrahepatic cholangiocarcinoma, distal cholangiocarcinoma, or gallbladder cancer.
- Concurrent lymph node or distant metastasis. Previous systemic treatment for biliary tract tumors. History of severe hypersensitivity reactions to other monoclonal antibodies. Allergy to durvalumab, adebrelimab, or any of their excipients; allergy to gemcitabine or any of its excipients; allergy to cisplatin or any of its excipients.
- Presence of pericardial effusion, uncontrolled pleural effusion, or clinically significant ascites within 7 days before treatment, defined as meeting the following criteria: (a) ascites detectable by physical examination during screening, or (b) ascites requiring paracentesis during screening.
- Any bleeding or thrombotic disorder or any need for anticoagulants requiring monitoring of the international normalized ratio (e.g., warfarin or similar drugs) within 6 months before treatment initiation.
- Presence of any malignancy other than the cholangiocarcinoma under study in this clinical trial and locally recurrent cancers that have been cured (e.g., resected basal cell or squamous cell skin cancer, superficial bladder cancer, cervical or breast cancer in situ, occult thyroid cancer).
- Presence of any known central nervous system metastases and/or leptomeningeal disease before treatment.
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- Any active immunodeficiency or autoimmune disease likely to recur at screening and/or any history of immunodeficiency or autoimmune antibody disease.
- Patients with immune system diseases requiring daily administration of more than 10 mg of dexamethasone.
- History of interstitial lung disease or non-infectious pneumonitis. Any severe chronic or active infection (excluding viral hepatitis) requiring systemic antibacterial, antifungal, or antiviral treatment (e.g., tuberculosis) before treatment initiation.
- Electrocardiogram (ECG) during screening shows a heart rate-corrected QT interval (QTc) (corrected using the Fridericia method) exceeding 450 milliseconds; Note: If any patient has a QTc interval exceeding 450 milliseconds on the first ECG, the ECG will be repeated to confirm the result.
- Any of the following cardiovascular risk factors: cardiogenic chest pain within 28 days before treatment, defined as moderate pain limiting daily activities (ADLs). Symptomatic pulmonary embolism within 28 days before treatment. History of acute myocardial infarction within 6 months before treatment.
- Any history of heart failure reaching New York Heart Association Class III or IV within 6 months after treatment, ventricular arrhythmia of Grade 2 or higher within 6 months before treatment, cerebrovascular accident (CVA), or transient ischemic attack (TIA) within 6 months before treatment.
- Organ transplantation or hematopoietic stem cell transplantation (HSCT) or any major surgery within 28 days before treatment.
- Known psychiatric or substance abuse disorders that may interfere with test compliance.
- Vaccination with a live vaccine within 28 days before treatment. Note: Seasonal influenza vaccines are generally inactivated and are permitted.
- Known history of human immunodeficiency virus (HIV) infection or syphilis infection.
- Any history or evidence of disease, treatment, or laboratory abnormalities that may confound test results, interfere with the subject's participation throughout the trial, or be deemed by the principal investigator as not in the subject's best interest.
- Pregnancy or lactation, or anticipated pregnancy or childbirth during the planned duration of the trial, from the screening visit to 120 days after the last dose.
- Poor compliance as judged by the investigator, or other conditions that make the patient unsuitable for participation in this trial.
- Various medical contraindications preventing the use of enhanced imaging (CT or MRI).
- The investigator deems the patient unsuitable for inclusion.
- -
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
Jinling Hospital of Nanjing University
Nanjing, Jiangsu, 210000
Yuan Cheng, 86 13915963713, 19656093@qq.com
Yuan Cheng
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210002
Xiangcheng Li, • 86 18951999088, drlixc@163.com
Changxian Li, • 86 18761854602, doclicx20@163.com
About this study
This study is a prospective, single-arm, phase II clinical trial designed to evaluate the safety and efficacy of PD-L1 monoclonal antibody combined with chemoradiotherapy as a bridge to liver transplantation in patients with locally advanced unresectable perihilar cholangiocarcinoma (pCCA).
Read the detailed description
Patients with locally advanced, unresectable pCCA who met the criteria as assessed by a multidisciplinary team (MDT) were enrolled after signing informed consent. They received three cycles of treatment with a PD-L1 monoclonal antibody combined with a gemcitabine + cisplatin regimen, followed by external beam radiotherapy (45 Gy/15 fractions) administered concurrently with oral capecitabine. Subsequently, they entered a maintenance therapy phase with capecitabine until liver transplantation (with a minimum of 4 weeks of discontinuation of immunotherapy prior to transplantation) or until disease progression/intolerable toxicity occurred.
Within two weeks prior to liver transplantation, a PET-CT scan was performed to exclude distant and occult metastases. Patients who passed the PET-CT staging screening and reached the drug washout period proceeded to the transplantation pathway.
Postoperatively, a standard immunosuppressive regimen was adopted, and oral capecitabine was administered for eight cycles as adjuvant therapy. All patients were followed up as scheduled to monitor for recurrence and survival.
- Being tested
- PD -1/PD-L1 monoclonal antibody plus radiotherapy and liver transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PD -1/PD-L1 monoclonal antibody plus radiotherapy and liver transplantationProcedure or surgery
After receiving treatment with a regimen combining PD-L1 inhibitor, gemcitabine, and cisplatin, patients underwent radiotherapy while concurrently taking oral capecitabine, followed by maintenance therapy with capecitabine until liver transplantation.
| Study group | Role | What they receive |
|---|---|---|
| PD-L1 combined with chemoradiotherapy as bridge to liver transplantation | Experimental | Patients received three cycles of treatment with a PD-L1 monoclonal antibody combined with a gemcitabine + cisplatin regimen, followed by external beam radiotherapy (45 Gy/15 fractions) administered concurrently with oral capecitabine. Subsequently, they entered a maintenance therapy phase with capecitabine until liver transplantation (with a minimum of 4 weeks of discontinuation of immunotherapy prior to transplantation) or until disease progression/intolerable toxicity occurred.
A PET-CT scan was performed within two weeks prior to liver transplantation to exclude distant and occult metastases. Patients who passed the PET-CT staging screening and reached the drug washout period proceeded to the transplantation pathway.
Postoperatively, a standard immunosuppressive regimen was adopted, and oral capecitabine was administered for eight cycles as adjuvant therapy. All patients were followed up as scheduled to monitor for recurrence and survival. Receives: Procedure: PD -1/PD-L1 monoclonal antibody plus radiotherapy and liver transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transplant Completion Rate, TCR
The proportion of patients who received neoadjuvant therapy and ultimately successfully underwent liver transplantation.
Measured: From the date of randomization until the date of first documented disease progression or the date of death from any cause, whichever occurs first, with an assessment period of up to 48 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2026
- Study start1 Mar 2026 (estimated)
- Primary completion1 Mar 2029 (estimated)
- Study completion1 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Perihilar 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
- Model description
- PD-L1 Monoclonal Antibody + Chemoradiotherapy
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiangcheng Li, Principal investigator, The First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, China 210002
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07471165
- Sponsor's protocol ID
- 2025-SR-1173
- Acronym
- ACHIEVE-LT
- Status last verified
- Feb 2026
- First submitted
- 13 Feb 2026
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-Arm, Phase II Study: PD-L1 Monoclonal Antibody + Chemoradiotherapy as Bridge Therapy to Liver Transplantation for Locally Advanced Perihilar Cholangiocarcinoma (ACHIEVE-LT)
- ClinicalTrials.gov ID
- NCT07471165
- Acronym / sponsor ID
- ACHIEVE-LT / 2025-SR-1173
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 1 Mar 2029 (estimated)
- Study completion
- 1 Jul 2029 (estimated)
- First posted
- 13 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.
This study is a prospective, single-arm, phase II clinical trial designed to evaluate the safety and efficacy of PD-L1 monoclonal antibody combined with chemoradiotherapy as a bridge to liver transplantation in patients with locally advanced unresectable perihilar cholangiocarcinoma (pCCA).
Detailed description
Patients with locally advanced, unresectable pCCA who met the criteria as assessed by a multidisciplinary team (MDT) were enrolled after signing informed consent. They received three cycles of treatment with a PD-L1 monoclonal antibody combined with a gemcitabine + cisplatin regimen, followed by external beam radiotherapy (45 Gy/15 fractions) administered concurrently with oral capecitabine. Subsequently, they entered a maintenance therapy phase with capecitabine until liver transplantation (with a minimum of 4 weeks of discontinuation of immunotherapy prior to transplantation) or until disease progression/intolerable toxicity occurred.
Within two weeks prior to liver transplantation, a PET-CT scan was performed to exclude distant and occult metastases. Patients who passed the PET-CT staging screening and reached the drug washout period proceeded to the transplantation pathway.
Postoperatively, a standard immunosuppressive regimen was adopted, and oral capecitabine was administered for eight cycles as adjuvant therapy. All patients were followed up as scheduled to monitor for recurrence and survival.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- PD-L1 Monoclonal Antibody + Chemoradiotherapy
| Arm | Type | Receives |
|---|---|---|
| PD-L1 combined with chemoradiotherapy as bridge to liver transplantation | Experimental | Procedure: PD -1/PD-L1 monoclonal antibody plus radiotherapy and liver transplantationPatients received three cycles of treatment with a PD-L1 monoclonal antibody combined with a gemcitabine + cisplatin regimen, followed by external beam radiotherapy (45 Gy/15 fractions) administered concurrently with oral capecitabine. Subsequently, they entered a maintenance therapy phase with capecitabine until liver transplantation (with a minimum of 4 weeks of discontinuation of immunotherapy prior to transplantation) or until disease progression/intolerable toxicity occurred. A PET-CT scan was performed within two weeks prior to liver transplantation to exclude distant and occult metastases. Patients who passed the PET-CT staging screening and reached the drug washout period proceeded to the transplantation pathway. Postoperatively, a standard immunosuppressive regimen was adopted, and oral capecitabine was administered for eight cycles as adjuvant therapy. All patients were followed up as scheduled to monitor for recurrence and survival. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- The patient voluntarily participates in this study and signs an informed consent form.
- The patient is aged between 18 and 70 years old.
- The patient has pathologically confirmed locally advanced perihilar cholangiocarcinoma (pCCA) without concurrent lymph node or distant metastasis, and meets at least one of the following criteria:
- Bile duct invasion: involvement of bilateral secondary bile ducts.
- Portal vein invasion: involvement of unilateral or bilateral branches and the main trunk.
Key exclusion criteria (22 listed)
- Diagnosed with intrahepatic cholangiocarcinoma, distal cholangiocarcinoma, or gallbladder cancer.
- Concurrent lymph node or distant metastasis. Previous systemic treatment for biliary tract tumors. History of severe hypersensitivity reactions to other monoclonal antibodies. Allergy to durvalumab, adebrelimab, or any of their excipients; allergy to gemcitabine or any of its excipients; allergy to cisplatin or any of its excipients.
- Presence of pericardial effusion, uncontrolled pleural effusion, or clinically significant ascites within 7 days before treatment, defined as meeting the following criteria: (a) ascites detectable by physical examination during screening, or (b) ascites requiring paracentesis during screening.
- Any bleeding or thrombotic disorder or any need for anticoagulants requiring monitoring of the international normalized ratio (e.g., warfarin or similar drugs) within 6 months before treatment initiation.
- Presence of any malignancy other than the cholangiocarcinoma under study in this clinical trial and locally recurrent cancers that have been cured (e.g., resected basal cell or squamous cell skin cancer, superficial bladder cancer, cervical or breast cancer in situ, occult thyroid cancer).
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 |
|---|---|---|
| PD -1/PD-L1 monoclonal antibody plus radiotherapy and liver transplantationAfter receiving treatment with a regimen combining PD-L1 inhibitor, gemcitabine, and cisplatin, patients underwent radiotherapy while concurrently taking oral capecitabine, followed by maintenance therapy with capecitabine until liver transplantation. | Procedure or surgery | PD-L1 combined with chemoradiotherapy as bridge to liver transplantation |
Primary outcome
Transplant Completion Rate, TCR
Time frame: From the date of randomization until the date of first documented disease progression or the date of death from any cause, whichever occurs first, with an assessment period of up to 48 months.
The proportion of patients who received neoadjuvant therapy and ultimately successfully underwent liver transplantation.
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 13 Mar 2026.
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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.
Xiangcheng Li principal investigator
The First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, China 210002
2 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 PD -1/PD-L1 monoclonal antibody plus radiotherapy and liver transplantation in people with Locally Advanced Perihilar Cholangiocarcinoma, run by The First Affiliated Hospital with Nanjing Medical 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 24 inclusion and 22 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 13 Mar 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.
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 Xiangcheng Li (• 86 18951999088, drlixc@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transplant Completion Rate, TCR (time frame: From the date of randomization until the date of first documented disease progression or the date of death from any cause, whichever occurs first, with an assessment period of up to 48 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 13 Mar 2026.