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Biliary Tract Neoplasms ImmunotherapyPhase 2NCT07679399

A Phase II Study of Adjuvant Durvalumab Combined With GEMOX/GC Chemotherapy Followed by Lenvatinib Versus Capecitabine in Biliary Tract Cancer.

A Phase 2 study testing Durvalumab plus GEMOX/GC chemotherapy sequentially followed by lenvatinib and Capecitabine in people with Biliary Tract Neoplasms Immunotherapy, run by Peking Union Medical College Hospital at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This study is designed as a prospective, randomized, open-label, phase II clinical trial to systematically evaluate the efficacy and safety of durvalumab combined with GEMOX/GC chemotherapy followed by lenvatinib, compared with capecitabine monotherapy, as adjuvant therapy for biliary tract cancer (BTC) after… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Biliary Tract Neoplasms Immunotherapy
What is being tested?
Durvalumab plus GEMOX/GC chemotherapy sequentially followed by lenvatinib and Capecitabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
222 participants
Where
1 siteChina
Study dates
1 Jun 2025to 1 Jun 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 subjects voluntarily participated in the study and agreed to sign the written informed consent. They had good compliance and cooperated with the follow-up.
  • When signing the informed consent form, one must be at least 18 years old and no older than 75 years old, and there is no restriction on gender.
  • Histologically confirmed cholangiocarcinoma or gallbladder cancer (excluding pancreatic cancer or ampullary cancer)
  • Having undergone radical surgical treatment (R0 or R1 resection)
  • The ECOG score is between 0 and 1
  • The hematology and organ functions are adequate. Based on the following laboratory test results obtained within 14 days prior to the start of the treatment (unless otherwise specified)
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  • Blood routine test: (Within 14 days before screening, no blood transfusion, no use of G-CSF, and no use of drugs for correction) Hb ≥ 90 g/L; Neutrophils ≥ 1.5 × 10^9/L; PLT ≥100×10^9/L
  • Biochemical test: (No albumin transfusion within 14 days)
  • Appropriate liver function: ALT and AST ≤ 2.5 × ULN; serum bilirubin ≤ 2.0 × normal upper limit (ULN); these conditions do not apply to patients with confirmed Gilbert syndrome. Any clinically significant biliary obstruction should be relieved before enrollment. Albumin ≥ 2.8 g/dL. Appropriate renal function: creatinine ≤ 1.5 × ULN, or creatinine clearance rate (CCr) > 50 mL/min (calculated using the standard Cockcroft-Gault formula)
  • Coagulation function: International Normalized Ratio (INR) ≤ 1.5
  • Fertile women: Agree to abstain from sexual intercourse (avoiding heterosexual intercourse) or use a contraceptive method with a failure rate of less than 1% during the treatment period and for at least 6 months after the last administration. If the female patient has menstruated, has not reached post-menopausal status (continuous absence of menstruation for ≥ 12 months, no other causes found apart from menopause), and has not undergone sterilization surgery (removal of ovaries and/or uterus), then it is considered that the patient is fertile. Examples of contraceptive methods with a failure rate of less than 1% include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormonal release intrauterine devices, and copper intrauterine devices. The reliability of sexual abstinence should be evaluated relative to the duration of the clinical trial and the patient's preferred lifestyle and daily routine. Periodic abstinence (such as calendar days, ovulation period, symptom-based body temperature, or post-ovulation methods) and withdrawal from sexual intercourse are unacceptable contraceptive methods.
  • Male: Agree to abstinence (not engaging in heterosexual sexual intercourse) or use of contraceptive measures, agree not to donate sperm, defined as follows: When the female partner has reproductive capacity, the male patient must abstain from sexual activity during the treatment period and for 6 months after the last administration, or use condoms and other contraceptive methods to ensure a contraceptive failure rate of less than 1% per year. During the same period, the male patient must also agree not to donate sperm. When the female partner is pregnant, the male patient must abstain from sexual activity or use condoms for contraception during the treatment period and for 6 months after the last administration, to avoid any impact on the fetus. The reliability of sexual abstinence should be evaluated relative to the duration of the clinical trial and the patient's preferred lifestyle and daily routine. Periodic abstinence (such as calendar days, ovulation period, symptom-based body temperature or after ovulation methods) and withdrawal from sexual intercourse are unacceptable contraceptive methods.

Who cannot join

  • Pancreatic cancer or ampullary cancer
  • Not yet fully recovered from the surgery or with unremoved bile duct obstruction
  • Pregnant women (with a positive pregnancy test before taking the medicine) or lactating women
  • Having had other untreated malignant tumors in the past (within the last 5 years) or simultaneously, excluding cured skin basal cell carcinoma, skin squamous cell carcinoma, in situ breast cancer and in situ cervical cancer, treated superficial bladder cancer, and prostate adenocarcinoma that underwent surgical treatment and whose PSA tumor marker was within the normal range.
  • Who has previously received immunotherapy or chemotherapy
  • Serious coexisting diseases that may interfere with the treatment of the proposed plan, including potential severe infections
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  • There is drug abuse; or any medical, psychological or social condition that may affect the research, the patient's compliance, be unstable, or even potentially endanger the patient's safety.
  • Significant clinical cardiovascular and cerebrovascular diseases, including but not limited to acute myocardial infarction occurring within 6 months prior to enrollment, severe/unstable angina pectoris, cerebrovascular accident or transient cerebral ischemic attack, congestive heart failure (NYHA classification ≥ 2 grade); arrhythmias requiring anti-arrhythmic drugs (except beta-blockers or digoxin); repeated electrocardiogram QTc interval > 480 milliseconds (ms)
  • Presence of persistent infection of grade 2 or above (CTCAE 5.0)
  • Having a history of thromboembolic events within the past 6 months (including stroke and/or transient ischemic attack)
  • Hypertension that has not been well controlled by antihypertensive drugs (systolic blood pressure > 160 mmHg, diastolic blood pressure > 100 mmHg)
  • Participants who had active autoimmune diseases or autoimmune disease history in the past two years; those with active, known, or suspected autoimmune diseases that may affect important organ functions or that may require systemic immunosuppressive therapy, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, antiphospholipid syndrome related to vascular thrombosis, Wegener's granulomatosis, Sjogren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis or glomerulonephritis. However, type 1 diabetes, hypothyroidism requiring only hormone replacement, skin diseases that do not require systemic treatment (such as vitiligo, psoriasis or alopecia) or participants who will not have a recurrence without external triggering factors are allowed. Alternative therapies (such as thyroid hormone, insulin or physiological corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) are not considered as a form of systemic treatment.
  • A known history of active tuberculosis (with the tuberculosis bacteria)
  • Those who have a history of gastrointestinal bleeding within the past 6 months or have a clear tendency towards gastrointestinal bleeding, such as esophageal varices with bleeding risk, active gastrointestinal ulcer lesions, or fecal occult blood ≥ (++), are not eligible for enrollment; those with evidence or history of ≥ 3 grade (CTCAE 5.0) bleeding events due to bleeding mechanism disorders are also excluded.
  • Severe non-healing wounds, ulcers or fractures
  • There are unresolved toxicities of grade > 1 that were caused by any previous treatment/operation (CTCAE 5.0, except for hair loss, anemia, and hypothyroidism)
  • Patients who have objective evidence of severe lung function impairment in the past and at present, such as a history of severe pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, or drug-related pneumonia
  • After the researchers' comprehensive assessment of the patient's condition, it was determined that the patient was not suitable for participating in this study.
  • At the same time, he/she was also involved in another clinical study.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Shuman Kuang contact

+86-10-69156042

kuangshuman@163.com

China1 site, 1 recruiting

  • Chinese Academy of Medical Sciences & Peking Union Medical College Hospital (CAMS&PUMCH), Beijing, 100730

    Beijing

    Haitao Zhao, Professor, +861069156042, zhaoht@pumch.cn

    Recruiting

Other trials in China

About this study

Official title: A Randomized, Open-label, Phase II Clinical Study of Durvalumab Combined With GEMOX/GC Chemotherapy Followed by Lenvatinib Versus Capecitabine as Adjuvant Therapy for Biliary Tract Cancer.

This study is designed as a prospective, randomized, open-label, phase II clinical trial to systematically evaluate the efficacy and safety of durvalumab combined with GEMOX/GC chemotherapy followed by lenvatinib, compared with capecitabine monotherapy, as adjuvant therapy for biliary tract cancer (BTC) after curative-intent resection.The primary objective is to determine whether the combination regimen can significantly improve the 1-year recurrence-free survival (RFS) rate. Secondary objectives include assessment of overall survival (OS) and the incidence of treatment-related adverse events. The overall aim is to identify a more effective and safer treatment strategy for postoperative adjuvant therapy in BTC.

Being tested
Durvalumab plus GEMOX/GC chemotherapy sequentially followed by lenvatinib, Capecitabine
Keywords
Biliary Tract Cancer, durvalumab, lenvatinib, capecitabine, adjuvant 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.

  • Durvalumab plus GEMOX/GC chemotherapy sequentially followed by lenvatinibCombination product

    Regimen of durvalumab plus GEMOX/GC chemotherapy sequentially followed by lenvatinib

  • CapecitabineDrug

    Capecitabine monotherapy regimen

Study groups in NCT07679399
Study groupRoleWhat they receive
Control arm (standard-of-care group)ExperimentalCapecitabine monotherapy regimen
Receives: Drug: Capecitabine
Experimental arm (combination arm)ExperimentalRegimen of durvalumab plus GEMOX/GC chemotherapy sequentially followed by lenvatinib
Receives: Combination Product: Durvalumab plus GEMOX/GC chemotherapy sequentially followed by lenvatinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 1-year recurrence-free survival

    1-year recurrence-free survival refers to the proportion of patients who remain alive and free of disease recurrence at 12 months after the initiation of treatment (e.g., surgery or start of systemic therapy).

    Measured: through study completion, an average of 1 year

Secondary outcomes (3)

  1. Overall Survival

    Overall Survival (OS) was defined as the time from randomization (or treatment initiation) to death from any cause.

    Measured: through study completion, an average of 1 year

  2. Adverse reaction event

    Blood test，Outpatient follow-up and telephone follow-up

    Measured: through study completion, an average of 1 year

  3. Serious adverse events

    SAEs were prospectively collected through electronic medical records.

    Measured: through study completion, an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jul 2026
  2. Study start1 Jun 2025
  3. Primary completion1 Jan 2027 (estimated)
  4. Study completion1 Jun 2027 (estimated)

Resources

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
222 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07679399
Sponsor's protocol ID
YFF001
Status last verified
Jun 2025
First submitted
19 May 2026
Last updated
1 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Durvalumab plus GEMOX/GC chemotherapy sequentially followed by lenvatinib and Capecitabine in people with Biliary Tract Neoplasms Immunotherapy, run by Peking Union Medical College 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 12 inclusion and 19 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 1 Jul 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 Shuman Kuang (+86-10-69156042, kuangshuman@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

1-year recurrence-free survival (time frame: through study completion, an average of 1 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 NCT07679399.

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 1 Jul 2026.

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