Gallbladder CarcinomaPhase 2NCT03702491
Apapitatin Combined With SOX for Palliative Adjuvant Chemotherapy in Patients With Advanced Gallbladder Carcinoma
A Phase 2 study testing Apatinib and Tegafur in people with Gallbladder Carcinoma, run by Eastern Hepatobiliary Surgery Hospital at 1 site in China.
Trial summary
A Single-center Open, Randomized, Controlled Study to Compare the Apapitatin Mesylate Combined With SOX Regimen and SOX Regimen for Palliative Adjuvant Chemotherapy in Patients With Advanced Gallbladder Carcinoma Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gallbladder Carcinoma
- What is being tested?
- Apatinib and Tegafur
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 1 siteChina
- Study dates
- 10 Aug 2018to 10 Aug 2020
- 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
- ages 18 to 75
- UICC/AJCC gallbladder TNM staging (The eighth edition), Ⅲ B - ⅣB (excluding M1) postoperative pathological diagnosis of gallbladder carcinoma;Patients confirmed to have undergone R1/R2 cholecystectomy or palliative surgery;
- The primary treatment is surgical resection or potentially resectable cholecystic carcinoma without other treatment
- ECOG performance status ≤1
- The liver and kidney function meets the following conditions： BIL<3 normal value upper limit (ULN)；ALT and AST< 2.5 xULN;Serum Cr≤ 1xULN,Clearance rate of endogenous creatinine>50ml/min（Cockcroft-Gault）;
- Other test rooms meet the following requirements:
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- Hemoglobin ≥ 90 g/L (no blood transfusion within 14 days)；Neutrophilic granulocyte count > 1.5x109 /L;The platelet count ≥ 80 x 10 ^ 9/L;
- Estimated life expectancy > 3 months.
- Before the enrollment, the heart function is good. There is no episode of myocardial infarction within half a year. For example, if you have hypertension or coronary heart disease, you should ensure that it is within the controllable range.
- Patient able and willing to provide written informed consent and to comply with the study protocol and Good compliance, with follow-up.
Who cannot join
- Non gallbladder carcinoma
- Significant clinical bleeding symptoms or a clear tendency to bleed occurred within the first month of randomization, such as cough/hemoptysis of 2.5ml or more, gastrointestinal bleeding, esophagogastric varices at risk of bleeding, hemorrhagic gastric ulcer, etc.
- Other topical treatments during the study (including intraperitoneal chemotherapy, radiotherapy, etc.)
- Pregnant or lactating women；
- Those who suffer from high blood pressure and cannot be treated to the normal range by antihypertensive drugs；
- HIV infection or the presence of AIDS-related diseases, or severe acute and chronic diseases;
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- Have grade II or higher myocardial ischemia or myocardial infarction、Poorly controlled arrhythmia；
- Severe active infections；
- There are secondary malignant tumors or other tumors within 3 years before the start of the study and there is metastasis of the brain or meninges.
- Researchers believe that their compliance is poor
- There are contraindications for Apatinib and S-1
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
xiao qing xiao qing Jiang
Shanghai, Shanghai Municipality
xiao q xiao qing Jiang, 13801603438 ext. 13801603438, Jxq1225@sina.com
About this study
Official title: A Single-center Open, Randomized, Controlled Study to Compare the Apapitatin Combined With SOX and SOX for Palliative Adjuvant Chemotherapy in Patients With Advanced Gallbladder Carcinoma
A Single-center Open, Randomized, Controlled Study to Compare the Apapitatin Mesylate Combined With SOX Regimen and SOX Regimen for Palliative Adjuvant Chemotherapy in Patients With Advanced Gallbladder Carcinoma
Read the detailed description
The aim of the study is to observe and evaluate the progression-free survival time (PFS), overall survival time (OS) and safety of patients with advanced Gallbladder Carcinoma treated with apatinib mesylate combined with SOX
- Conditions
- Gallbladder Carcinoma
- Being tested
- Apatinib, Tegafur
- Medical subject headings
- Gallbladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApatinibDrug
Also called Tegafur, Oxaliplatin
Three to four weeks after surgery, the SOX regimen was given palliative adjuvant chemotherapy for 6-8 cycles, then followed by the second cycle combined with the treatment of apatinib mesylate and the monotherapy maintenance of apatinib mesylate
TegafurDrug
Also called Oxaliplatin
3-4 weeks after operation, 6-8 cycles of adjuvant chemotherapy with simple SOX protocol were given.
| Study group | Role | What they receive |
|---|---|---|
| Apatinib with SOX(Tegafur,Oxaliplatin) | Experimental | Patients 3-4 weeks after surgery, the SOX regimen was given palliative adjuvant chemotherapy for 6-8 cycles, then followed by the second cycle combined with the treatment of apatinib mesylate and the monotherapy maintenance of apatinib mesylate Receives: Drug: Apatinib |
| SOX( Tegafur,Oxaliplatin) | Active comparator | 3-4 weeks after operation, 6-8 cycles of adjuvant chemotherapy with simple SOX protocol were given. Receives: Drug: Tegafur |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
progression-free survival
Measured: 12 month after first treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2018
- Study start10 Aug 2018
- Primary completion10 Aug 2020 (estimated)
- Study completion10 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gallbladder CarcinomaStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 138 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eastern Hepatobiliary Surgery Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaoqing Jiang, Eastern Hepatobiliary Surgery Hospital
- Investigators
- xiao qing Jiang, professor, Principal investigator, 700 Moyu Road North, Jiading District,Eastern Hepatobiliary Surgery Hospital, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03702491
- Sponsor's protocol ID
- XJiang
- Status last verified
- Aug 2018
- First submitted
- 7 Oct 2018
- Last updated
- 11 Oct 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center Open, Randomized, Controlled Study to Compare the Apapitatin Combined With SOX and SOX for Palliative Adjuvant Chemotherapy in Patients With Advanced Gallbladder Carcinoma
- ClinicalTrials.gov ID
- NCT03702491
- Acronym / sponsor ID
- XJiang
- Conditions
- Gallbladder Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- Eastern Hepatobiliary Surgery HospitalUniversity, hospital or other
- Study start
- 10 Aug 2018 (actual)
- Primary completion
- 10 Aug 2020 (estimated)
- Study completion
- 10 Aug 2020 (estimated)
- First posted
- 11 Oct 2018 (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.
A Single-center Open, Randomized, Controlled Study to Compare the Apapitatin Mesylate Combined With SOX Regimen and SOX Regimen for Palliative Adjuvant Chemotherapy in Patients With Advanced Gallbladder Carcinoma
Detailed description
The aim of the study is to observe and evaluate the progression-free survival time (PFS), overall survival time (OS) and safety of patients with advanced Gallbladder Carcinoma treated with apatinib mesylate combined with SOX
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Apatinib with SOX(Tegafur,Oxaliplatin) | Experimental | Drug: ApatinibPatients 3-4 weeks after surgery, the SOX regimen was given palliative adjuvant chemotherapy for 6-8 cycles, then followed by the second cycle combined with the treatment of apatinib mesylate and the monotherapy maintenance of apatinib mesylate |
| SOX( Tegafur,Oxaliplatin) | Active comparator | Drug: Tegafur3-4 weeks after operation, 6-8 cycles of adjuvant chemotherapy with simple SOX protocol were given. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- ages 18 to 75
- UICC/AJCC gallbladder TNM staging (The eighth edition), Ⅲ B - ⅣB (excluding M1) postoperative pathological diagnosis of gallbladder carcinoma;Patients confirmed to have undergone R1/R2 cholecystectomy or palliative surgery;
- The primary treatment is surgical resection or potentially resectable cholecystic carcinoma without other treatment
- ECOG performance status ≤1
- The liver and kidney function meets the following conditions： BIL<3 normal value upper limit (ULN)；ALT and AST< 2.5 xULN;Serum Cr≤ 1xULN,Clearance rate of endogenous creatinine>50ml/min（Cockcroft-Gault）;
Key exclusion criteria (11 listed)
- Non gallbladder carcinoma
- Significant clinical bleeding symptoms or a clear tendency to bleed occurred within the first month of randomization, such as cough/hemoptysis of 2.5ml or more, gastrointestinal bleeding, esophagogastric varices at risk of bleeding, hemorrhagic gastric ulcer, etc.
- Other topical treatments during the study (including intraperitoneal chemotherapy, radiotherapy, etc.)
- Pregnant or lactating women；
- Those who suffer from high blood pressure and cannot be treated to the normal range by antihypertensive drugs；
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 |
|---|---|---|
| ApatinibAlso: Tegafur, OxaliplatinThree to four weeks after surgery, the SOX regimen was given palliative adjuvant chemotherapy for 6-8 cycles, then followed by the second cycle combined with the treatment of apatinib mesylate and the monotherapy maintenance of apatinib mesylate | Drug | Apatinib with SOX(Tegafur,Oxaliplatin) |
| TegafurAlso: Oxaliplatin3-4 weeks after operation, 6-8 cycles of adjuvant chemotherapy with simple SOX protocol were given. | Drug | SOX( Tegafur,Oxaliplatin) |
Primary outcome
PFS
Time frame: 12 month after first treatment
progression-free survival
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2018.
- Individual participant dataSharing planned: No
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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.
xiao qing Jiang, professor principal investigator
700 Moyu Road North, Jiading District,Eastern Hepatobiliary Surgery Hospital, Shanghai, China
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 Apatinib and Tegafur in people with Gallbladder Carcinoma, run by Eastern Hepatobiliary Surgery Hospital 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 10 inclusion and 11 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 11 Oct 2018. 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 xiao qing Jiang, professor (13801603438 ext. 13801603438, Jxq1225@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: 12 month after first treatment). 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 11 Oct 2018; AzTrials last refreshed its copy on 7 Nov 2026.