CholangioadenomaPhase 2RALOXBTCNCT05148143
RALOX as Second Line Treatment for Advanced Malignant Biliary System Tumor
A Phase 2 study testing Raltitrexed combined with oxaplatin in people with Cholangioadenoma, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cholangioadenoma
- What is being tested?
- Raltitrexed combined with oxaplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2020to 31 Dec 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
the Second Affiliated Hospital of Medical College of Zhejiang University
Hangzhou, Zhejiang, 310000
Ying Yuan, 13858193601, yuanying1999@zju.edu.cn
Ying Yuan, Ph.D & MD
About this study
Official title: Raltitrexed Combined With Oxaplatin as Second Line Treatment for Advanced Malignant Biliary System Tumor
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.
Read the 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.
- Conditions
- Cholangioadenoma
- Being tested
- Raltitrexed combined with oxaplatin
- Keywords
- cholangioadenoma, first line treatment failure, raltitrexed;, oxaliplatin
- Medical subject headings
- Adenoma, Bile Duct
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Raltitrexed combined with oxaplatinDrug
Also called Sai Wei Jian
Raltitrexed combined with oxaplatin as second line treatment of cholangiocarcinoma
| Study group | Role | What they receive |
|---|---|---|
| RALOX | Experimental | Raltitrexed combined with oxaplatin Receives: Drug: Raltitrexed combined with oxaplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months
Secondary outcomes (5)
ORR
Overall Response Rate
Measured: 24 months
OS
Overall Survival
Measured: 36 months
DCR
Disease Control Rate
Measured: 24 months
Qol ( quality of life )
EORTC-QLQ-C30 is a cancer-specific instrument
Measured: 24 months
AE
Adverse Event
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2021
- Study start1 Jun 2020
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholangioadenomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ying Yuan, Ph.D&MD, Principal investigator, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05148143
- Sponsor's protocol ID
- RALOX 202102
- Acronym
- RALOXBTC
- Status last verified
- Aug 2021
- First submitted
- 18 Nov 2021
- Last updated
- 8 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Raltitrexed Combined With Oxaplatin as Second Line Treatment for Advanced Malignant Biliary System Tumor
- ClinicalTrials.gov ID
- NCT05148143
- Acronym / sponsor ID
- RALOXBTC / RALOX 202102
- Conditions
- Cholangioadenoma
- Keywords
- cholangioadenoma, first line treatment failure, raltitrexed;, oxaliplatin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 8 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RALOX | Experimental | Drug: Raltitrexed combined with oxaplatinRaltitrexed combined with oxaplatin |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Raltitrexed combined with oxaplatinAlso: Sai Wei JianRaltitrexed combined with oxaplatin as second line treatment of cholangiocarcinoma | Drug | RALOX |
Primary outcome
PFS（Progression Free Survival）
Time frame: 24 months
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.
5 secondary outcomes
ORR
Time frame: 24 months
OS
Time frame: 36 months
DCR
Time frame: 24 months
Qol ( quality of life )
Time frame: 24 months
AE
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2021.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ying Yuan, Ph.D&MD principal investigator
Second Affiliated Hospital, Zhejiang University, School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Raltitrexed combined with oxaplatin in people with Cholangioadenoma, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ying Yuan, Ph.D&MD (13858193601, yuanying1999@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS（Progression Free Survival） (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2021.