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Active, not recruitingNCT05451290Updated Feb 12, 2026

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

A Phase 2 interventional study of Camrelizumab, apatinib, gemcitabine, oxaliplatin, tegafur in Advanced Biliary Tract Carcinoma, sponsored by First Affiliated Hospital of Zhejiang University. Active, not recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-02-12.

Sponsored by First Affiliated Hospital of Zhejiang University · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Advanced Biliary Tract Carcinoma
03

In context

Lead sponsor

First Affiliated Hospital of Zhejiang University is the lead sponsor of 255 studies on the registry; 139 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Informed consent document must be signed.
  2. Aged 18-75 years old, both genders.
  3. Pathologically confirmed biliary tract adenocarcinoma and haven't been treated before.
  4. An Eastern Cooperative Oncology Group performance status of 0 to 1.
  5. Locally advanced biliary tract adenocarcinoma confirmed by MDT discussion.
  6. The function of vital organs meets the following requirements:

    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.

  7. At least 1 measurable lesion as defined by RECIST 1.1.
  8. Women of reproductive age need to take effective contraceptive measures during and within 3 months of the end of medication.
  9. Subjects should have good compliance and cooperate with the follow-up.

Exclusion criteria

Exclusion Criteria:

  1. 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.
  2. Subjects with illness or medical conditions that could jeopardize their sugery, such as severe cardiopulmonary insufficiency and coagulation disorders, cannot be enrolled.
  3. 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.
  4. 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.
  5. 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.
  6. Subjects with history of neurological or psychiatric disease, including epilepsy or dementia or diseases alike should not be enrolled.
  7. Subjects with interstitial lung disease or a history of interstitial pneumonia should not be enrolled.
  8. Subjects who had participated in other anti-tumor clinical trials within 4 weeks prior to enrollment should be avoided.
  9. Subjects who had used PD-1/PD-L1 or other antitumor immunotherapeutic agents prior to enrollment should be avoided.
  10. The following subjects should be avoided: pregnant or lactating women; those who have childbearing potential and unwilling or unable to use effective contraception measures.
  11. Other circumstances that could affect the trial or the result of the study judged by the investigator.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    treatment arm

    Drug: Camrelizumab, apatinib, gemcitabine, oxaliplatin, tegafur

Interventions

  • DrugCamrelizumab, apatinib, gemcitabine, oxaliplatin, tegafur

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

    Also known as: surgery

06

What researchers measure

Primary outcomes

  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.

    Time frame: 1 year

Secondary outcomes

  1. R0 resection rate

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

    Time frame: up to 2 years

  2. Major pathologic response (MPR)

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

    Time frame: up to 2 years

  3. ORR

    The proportion of patients with a confirmed complete or partial response

    Time frame: up to 2 years

  4. DCR

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

    Time frame: 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.

    Time frame: up to 5 years

  6. OS

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

    Time frame: up to 5 years

  7. adverse event

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

    Time frame: up to 2 years

07

Study locations

1 site
  • the First Affiliated Hospital, School of Medicine, Zhejiang University
    Hangzhou, Zhejiang 310003, China
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05451290
Lead sponsor
First Affiliated Hospital of Zhejiang University
Responsible party
Sponsor
First posted
Jul 11, 2022
Start date
Nov 1, 2022
Primary completion
Dec 31, 2024
Completion
Dec 3, 2026 (estimated)
Last update
Feb 12, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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