RALOX as Second Line Treatment for Advanced Malignant Biliary System Tumor (RALOXBTC)

Zhejiang University

Status and phase: Unknown; Phase 2

Conditions: Cholangioadenoma

Treatments: Drug: Raltitrexed combined with oxaplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT05148143

RALOX 202102

Details and patient eligibility

About

The purpose of this study was to explore the safety and efficacy of raltitrexed combined with oxaplatin as second line treatment for advanced malignant biliary system tumor.

Full description

The purpose of this study was to explore the safety and efficacy of raltitrexed combined with oxaplatin as second line treatment for advanced malignant biliary system tumor. Single arm，phase II study for patients with cholangiocarcinoma or gallbladder carcinoma after first line treatment failure to explore effection and safety of raltitrexed combined with oxaplatin as second line treatment；Sample size：50.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

1. 18-75 years old.
2. Patients with unresectable advanced advanced Gallbladder carcinoma or Cholangiocarcinoma confirmed by histology or cytology.
3. First-line chemotherapy failure (toxic side effects can not be tolerated, disease progression during treatment or relapse after treatment) ;Or the disease recurred within 6 months after completion of adjuvant chemotherapy.
4. At least one measurable lesion according to RECIST1.1 criteria.
5. ECOG: 0 ~ 1.
6. Life expectancy ≥ 12 Weeks.
7. The major organs were functioning normally, and the laboratory examination results within 1 week met the following conditions before enrollment:①Absolute neutrophil count (ANC)≥1.5×109/L ②Platelet count（PLT）≥80.0 × 109/L ③Hemoglobin concentration（HB） ≥90g/L④ Total bilirubin（TB）≤1.5×ULN ⑤ Serum creatinine （Cr）≤l.5×ULN ，Endogenous creatinine clearance >60ml/min（Cockcroft-Gault Formula ）⑥Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Alkaline phosphatase(AP): ≤3 ×ULN (≤5 ×ULN for metastases to liver).
8. Sign the informed consent voluntarily.

Exclusion Criteria

1. Allergic to any research drug and its excipients.
2. Prior use of raltitrexed or oxaliplatin.
3. History of other malignancies, except cured Basal cell or squamous Cell Carcinoma of the skin and carcinoma in situ of the cervix.
4. There is a history of brain metastases.
5. History of psychotropic drug abuse and cannot quit or has a mental disorder.
6. Uncontrolled chronic infectious and non-infectious diseases.
7. Active or clinically poorly controlled severe infection
8. Other conditions that the researchers think should be ruled out.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

RALOX

Experimental group

Description:

Raltitrexed combined with oxaplatin

Treatment:

Drug: Raltitrexed combined with oxaplatin