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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.
Enrolled participants should be treated with neoadjuvant camrelizumab and apatinib and GEMOX, after surgery, be treated with adjuvant camrelizumab and S-1.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| treatment arm | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Camrelizumab, apatinib, gemcitabine, oxaliplatin, tegafur | Drug | Perioperative treatment: camrelizumab plus apatinib in combination with GEMOX 2-4 cycles (neoadjuvant); camrelizumab plus S-1 up to 1 year (adjuvant). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| R0 resection rate | The proportion of patients who underwent complete tumor resection with microscopically negative margins | up to 2 years |
| Major pathologic response (MPR) | 10% or less residual viable tumor cells in the resected specimen |
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Inclusion Criteria:
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:
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.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the First Affiliated Hospital, School of Medicine, Zhejiang University | Hangzhou | Zhejiang | 310003 | China |
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|
| up to 2 years |
| ORR | The proportion of patients with a confirmed complete or partial response | up to 2 years |
| DCR | The proportion of patients with a complete response, partial response, or stable disease | up to 2 years |
| 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. | up to 5 years |
| OS | The time from the first dose of study treatment to death from any cause | up to 5 years |
| adverse event | Based on the assessment using CTCAE v5.0, the safety was evaluated. | up to 2 years |
| ID | Term |
|---|---|
| C000631724 | camrelizumab |
| C553458 | apatinib |
| D000093542 | Gemcitabine |
| D000077150 | Oxaliplatin |
| D005641 | Tegafur |
| D013514 | Surgical Procedures, Operative |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
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