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Advanced Biliary Tract CarcinomaPhase 2NCT05451290

Camrelizumab Plus Apatinib in Combination With GEMOX (Gemcitabine and Oxaliplatin ) in Patients With Locally Advanced Biliary Tract Cancer

A Phase 2 study testing Camrelizumab, apatinib, gemcitabine, oxaliplatin, tegafur in people with Advanced Biliary Tract Carcinoma, run by First Affiliated Hospital of Zhejiang University at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This is a phase II open-label, one-arm, multicenter study aimed to explore the efficacy and safety of perioperative (neoadjuvant and adjuvant) treatment for patients with advanced biliary tract carcinoma. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Advanced Biliary Tract Carcinoma
What is being tested?
Camrelizumab, apatinib, gemcitabine, oxaliplatin, tegafur
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteChina
Study dates
1 Nov 2022to 3 Dec 2026
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

  • Informed consent document must be signed.
  • Aged 18-75 years old, both genders.
  • Pathologically confirmed biliary tract adenocarcinoma and haven't been treated before.
  • An Eastern Cooperative Oncology Group performance status of 0 to 1.
  • Locally advanced biliary tract adenocarcinoma confirmed by MDT discussion.
  • The function of vital organs meets the following requirements:
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  • the blood ANC count≥1.5x109 /L; hemoglobin ≥ 90 g/L，the blood platelet count≥80 x109 /L, total bilirubin ≤ 1.5 x ULN, ALT and AST ≤3 x ULN(< 5 x ULN for patients with live metastasis), serum creatinine≤1.5 x ULN, endogenous creatinine clearance rate ≥45ml/min.
  • At least 1 measurable lesion as defined by RECIST 1.1.
  • Women of reproductive age need to take effective contraceptive measures during and within 3 months of the end of medication.
  • Subjects should have good compliance and cooperate with the follow-up.

Who cannot join

  • Subject has any active autoimmune disease or history of autoimmune disease will not be included, nor will patients with active tuberculosis or hepatitis or HIV.
  • Subjects with illness or medical conditions that could jeopardize their sugery, such as severe cardiopulmonary insufficiency and coagulation disorders, cannot be enrolled.
  • Subjects with active malignancies other than BTC within 5 years should be excluded, except for cured basal cell carcinoma of the skin and carcinoma in situ of the cervix and superficial bladder cancer [Ta, Tis \& T1] and papillary thyroid cancer.
  • Any unstable systemic disease which might need systemic treatment should not be enrolled (including active infection, liver or renal disease, metabolic disease, acute cerebral infarction or hemorrhage), or serious co-morbidities that by the judgment of the investigator, may compromise the patient's safety or impair the patient's ability to complete the study.
  • Subjects who have significant cardiovascular events should not be enrolled, for example: congestive heart failure > NYHA class 2, unstable angina, active coronary artery disease (CAD) (only allow the subjects with presence of myocardial infarction more than 1 year prior to study); severe arrhythmias in need of treatment (only allow those been treated with β-blockers or digoxin) or uncontrolled hypertension.
  • Subjects with history of neurological or psychiatric disease, including epilepsy or dementia or diseases alike should not be enrolled.
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  • Subjects with interstitial lung disease or a history of interstitial pneumonia should not be enrolled.
  • Subjects who had participated in other anti-tumor clinical trials within 4 weeks prior to enrollment should be avoided.
  • Subjects who had used PD-1/PD-L1 or other antitumor immunotherapeutic agents prior to enrollment should be avoided.
  • The following subjects should be avoided: pregnant or lactating women; those who have childbearing potential and unwilling or unable to use effective contraception measures.
  • Other circumstances that could affect the trial or the result of the study judged by the investigator.

Trial locations and contacts

1 site in 1 country.

China1 site

  • the First Affiliated Hospital, School of Medicine, Zhejiang University

    Hangzhou, Zhejiang, 310003

Other trials in China

About this study

Official title: Camrelizumab Plus Apatinib Combined With GEMOX (Gemcitabine and Oxaliplatin ) in the Perioperative Treatment of Locally Advanced Biliary Tract Malignancies: A Prospective, Multicenter, Phase Ⅱ Study

This is a phase II open-label, one-arm, multicenter study aimed to explore the efficacy and safety of perioperative (neoadjuvant and adjuvant) treatment for patients with advanced biliary tract carcinoma.

Read the detailed description

Enrolled participants should be treated with neoadjuvant camrelizumab and apatinib and GEMOX, after surgery, be treated with adjuvant camrelizumab and S-1.

Being tested
Camrelizumab, apatinib, gemcitabine, oxaliplatin, tegafur

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Camrelizumab, apatinib, gemcitabine, oxaliplatin, tegafurDrug

    Also called surgery

    Perioperative treatment: camrelizumab plus apatinib in combination with GEMOX 2-4 cycles (neoadjuvant); camrelizumab plus S-1 up to 1 year (adjuvant).

Study groups in NCT05451290
Study groupRoleWhat they receive
treatment armExperimentalNot described
Receives: Drug: Camrelizumab, apatinib, gemcitabine, oxaliplatin, tegafur

What is being measured

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

  1. 1-year EFS rate

    EFS was defined as the time from the first administration of study treatment to the first occurrence of any of the following events: disease progression that precluded surgical resection, disease recurrence after curative-intent surgery, disease progression in patients who did not undergo surgery, or death from any cause. 1-year EFS rate was the incidence rate of event-free survival within one year.

    Measured: 1 year

Secondary outcomes (7)

  1. R0 resection rate

    The proportion of patients who underwent complete tumor resection with microscopically negative margins

    Measured: up to 2 years

  2. Major pathologic response (MPR)

    10% or less residual viable tumor cells in the resected specimen

    Measured: up to 2 years

  3. ORR

    The proportion of patients with a confirmed complete or partial response

    Measured: up to 2 years

  4. DCR

    The proportion of patients with a complete response, partial response, or stable disease

    Measured: up to 2 years

  5. EFS

    EFS was defined as the time from the first administration of study treatment to the first occurrence of any of the following events: disease progression that precluded surgical resection, disease recurrence after curative-intent surgery, disease progression in patients who did not undergo surgery, or death from any cause.

    Measured: up to 5 years

  6. OS

    The time from the first dose of study treatment to death from any cause

    Measured: up to 5 years

  7. adverse event

    Based on the assessment using CTCAE v5.0, the safety was evaluated.

    Measured: up to 2 years

Timeline

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

  1. First posted11 Jul 2022
  2. Study start1 Nov 2022
  3. Primary completion31 Dec 2024
  4. Study completion3 Dec 2026 (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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05451290
Sponsor's protocol ID
IIT20220057C
Status last verified
Feb 2026
First submitted
6 Jul 2022
Last updated
12 Feb 2026
Results posted
No
Data monitoring committee
No
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 Camrelizumab, apatinib, gemcitabine, oxaliplatin, tegafur in people with Advanced Biliary Tract Carcinoma, run by First Affiliated Hospital of Zhejiang University 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: under way, not looking for participants, as of the sponsor's last update on 12 Feb 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

1-year EFS rate (time frame: 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 NCT05451290.

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 12 Feb 2026.

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