RALOX as Second Line Treatment for Advanced Malignant Biliary System Tumor

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Brief Title

RALOX as Second Line Treatment for Advanced Malignant Biliary System Tumor

Official Title

Raltitrexed Combined With Oxaplatin as Second Line Treatment for Advanced Malignant Biliary System Tumor

Brief Summary

      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.
    

Detailed 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.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

PFS(Progression Free Survival)

Secondary Outcome

 ORR

Condition

Cholangioadenoma

Intervention

Raltitrexed combined with oxaplatin

Study Arms / Comparison Groups

 RALOX
Description:  Raltitrexed combined with oxaplatin

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

50

Start Date

June 1, 2020

Completion Date

December 31, 2023

Primary Completion Date

December 31, 2022

Eligibility 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.
      

Gender

All

Ages

18 Years - 75 Years

Accepts Healthy Volunteers

No

Contacts

Ying Yuan, Ph.D&MD, 13858193601, [email protected]

Location Countries

China

Location Countries

China

Administrative Informations


NCT ID

NCT05148143

Organization ID

RALOX 202102


Responsible Party

Sponsor

Study Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University


Study Sponsor

Ying Yuan, Ph.D&MD, Principal Investigator, Second Affiliated Hospital, School of Medicine, Zhejiang University


Verification Date

August 2021