RALOX as Second Line Treatment for Advanced Malignant Bil... | NCT05148143

Studies
RALOX as Second Line Treatment for Advanced Malignant Biliary System Tumor

NCT05148143

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Status

Unknown status

Last Update Posted

Dec 8, 2021Actual

Enrollment

50Estimated

Phase

Phase 2

Conditions

Cholangioadenoma

Interventions

Raltitrexed combined with oxaplatin

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2020Actual

Primary Completion Date

Dec 31, 2022Estimated

Completion Date

Dec 31, 2023Estimated

First Submitted Date

Nov 18, 2021

First Submission Date that Met QC Criteria

Dec 6, 2021

First Posted Date

Dec 8, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 6, 2021

Last Update Posted Date

Dec 8, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
RALOX	Experimental	Raltitrexed combined with oxaplatin	Drug: Raltitrexed combined with oxaplatin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Raltitrexed combined with oxaplatin	Drug	Raltitrexed combined with oxaplatin as second line treatment of cholangiocarcinoma	RALOX

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
PFS（Progression Free Survival）	PFS is defined as the time interval from initiation of treatment to the first date of documented tumor progression or death from any cause, whichever occurs first.	24 months

Secondary Outcomes

Measure	Description	Time Frame
ORR	Overall Response Rate	24 months
OS	Overall Survival	36 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria

18-75 years old.
Patients with unresectable advanced advanced Gallbladder carcinoma or Cholangiocarcinoma confirmed by histology or cytology.
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.
At least one measurable lesion according to RECIST1.1 criteria.
ECOG: 0 ~ 1.
Life expectancy ≥ 12 Weeks.
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).
Sign the informed consent voluntarily.

Exclusion Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ying Yuan, Ph.D&MD	Contact	13858193601		yuanying1999@zju.edu.cn

Overall Officials

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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
the Second Affiliated Hospital of Medical College of Zhejiang University	Recruiting	Hangzhou	Zhejiang	310000	China

ID	Term
D000236	Adenoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type
D009369	Neoplasms