Toripalimab Combined With S1 and Albumin Paclitaxel in Patients With Advanced Biliary Tract Cancer

Dai, Guanghai

Status and phase: Unknown; Phase 2

Conditions: Advanced Biliary Tract Cancer

Treatments: Drug: Toripalimab Combined With S1 and Albumin Paclitaxel

Study type: Interventional

Funder types: Other

Identifiers

NCT04027764

TSA-01

Details and patient eligibility

About

The investigator's study is a single armed phrase II trial ,aiming to improve the effecacy of treatment for advanced billiary tract cancer by means of Toripalimab combining with S1 and Albumin Paclitaxel as first line in patients with advanced Biliary Tract Cancer. treatment continually until disease progression or intolerable toxicity or Patients withdrawal of consent.and target sample is 30+ patients.

Full description

Toripalimab: 240 mg , once every 2-3 weeks; S1: 80-120mg, bid; oral, day1-14; Albumin paclitaxel: 120mg/m2 , administered on the first day and the eighth day of each cycle; 21 days for a treatment cycle

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age ≥ 18 years old
2. Patients with gallbladder and cholangiocarcinoma diagnosed by histology or cytology
3. Liver function Child-Pugh grade A (5-6 points) or better grade B (≤ 7 points)
4. ECOG score 0 or 1 point
5. At least one measurable lesion
6. no previous treatment

Exclusion criteria

1. organs failure ,including liver ,heart ,kidney
2. Have received a liver transplant in the past
3. Active brain metastasis or spinal cord compression
4. ECOG score 3 or 4 point
5. Symptomatic peripheral neuropathy (CTCAE ≥ 2)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Toripalimab Combined With S1 and Albumin Paclitaxel

Experimental group

Treatment:

Drug: Toripalimab Combined With S1 and Albumin Paclitaxel