Gastric CancerPhase 3NCT03598348
Evaluate the Efficacy of Maintenance Treatment With Capecitabine Plus Apatinib in Advanced Gastric Cancer
A Phase 3 study testing Apatinib+Capecitabine and Apatinib in people with Gastric Cancer, run by Huazhong University of Science and Technology at 1 site in China.
Trial summary
This is a multicenter, randomized, controlled trial to evaluate the efficacy and safety of Maintenance Treatment with Capecitabine plus Apatinib, Apatinib and Observation after First-line XELOX/SOX chemotherapy for Patients with Advanced Gastric Cancer Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Apatinib+Capecitabine and Apatinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 288 participants
- Where
- 1 siteChina
- Study dates
- 16 Jan 2018to 16 Oct 2020
- Phase
- Phase 3
- 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
- aged 18-75；
- had histologically confirmed unresectable and/or metastatic (primary or recurrent) adenocarcinoma of the stomach or gastroesophageal junction；
- received 4-6 cycles of Xelox/SOX regimens as first-line chemotherapy and the response was not progression disease (PD);
- ECOG 0-2；
- Patients were tested for tumor HER2 status before treatment, and patients with HER2-negative disease；
- presence of at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 guidelines；
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- Subjects has to voluntarily join the study and sign the Informed Consent Form for the study;
- Adequate organ function as defined below: Hematologic ANC ≥ 2*109/L, Platelets ≥ 100*109/L, AST and ALT ≤ 2.5×ULN, TBIL ≤ 1.5×ULN
- Receiving no form of chemotherapy, targeted therapy or other study medication;
Who cannot join
- previous radiotherapy to the abdomen；
- previous treatment for advanced disease (neoadjuvant chemotherapy was permitted if administered >6 months before enrollment)；
- pregnant or lactating women or women of childbearing potential；
- disease progression during the first-line chemotherapy;
- active gastrointestinal bleeding, arterial thrombosis or cerebrovascular accident within 6 months before enrollment
- previous treatment of apatinib and Ramucirumab
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Huazhong University of Science and Technology
Wuhan, Hubei, 430000
Xianglin Yuan, PhD,MD, 8627-83663406, xlyuan1020@163.com
Ping Peng, PhD,MD, 8627-83663407, pengpingtj@163.com
About this study
Official title: Maintenance Treatment With Capecitabine Plus Apatinib vs. Apatinib and Observation After First-line XELOX/SOX Chemotherapy for Patients With Advanced Gastric Cancer: a Multicenter, Randomized, Controlled Trial
This is a multicenter, randomized, controlled trial to evaluate the efficacy and safety of Maintenance Treatment with Capecitabine plus Apatinib, Apatinib and Observation after First-line XELOX/SOX chemotherapy for Patients with Advanced Gastric Cancer
- Conditions
- Gastric Cancer
- Being tested
- Apatinib+Capecitabine, Apatinib
- Keywords
- advanced gastric cancer, apatinib, capecitabine, maintenance
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apatinib+CapecitabineDrug
Also called apatinib, capecitabine
Capecitabine 1000mg/m2 po bid, d1-14, Apatinib 250mg po Qd, Q21d
ApatinibDrug
Apatinib 250mg po Qd
| Study group | Role | What they receive |
|---|---|---|
| Maintenance Treatment Group A | Experimental | Maintenance Treatment with Capecitabine plus Apatinib after First-line XELOX chemotherapy for Patients with Advanced Gastric Cancer Receives: Drug: Apatinib+Capecitabine |
| Observation Group | No intervention | Observation after First-line XELOX chemotherapy for Patients with Advanced Gastric Cancer |
| Maintenance Treatment Group B | Experimental | Maintenance Treatment with Apatinib after First-line XELOX chemotherapy for Patients with Advanced Gastric Cancer Receives: Drug: Apatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
Measured: 36 months
Secondary outcomes (1)
OS
From date of randomization until the date of first documented death from any cause, assessed up to 36 months
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start16 Jan 2018
- Primary completion16 Jan 2020 (estimated)
- Study completion16 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 288 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xianglin Yuan, Huazhong University of Science and Technology
- Investigators
- Xianglin Yuan, PhD,MD, Study chair, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03598348
- Sponsor's protocol ID
- TJCC006
- Status last verified
- Jul 2018
- First submitted
- 24 Dec 2017
- Last updated
- 26 Jul 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maintenance Treatment With Capecitabine Plus Apatinib vs. Apatinib and Observation After First-line XELOX/SOX Chemotherapy for Patients With Advanced Gastric Cancer: a Multicenter, Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT03598348
- Acronym / sponsor ID
- TJCC006
- Conditions
- Gastric Cancer
- Keywords
- advanced gastric cancer, apatinib, capecitabine, maintenance
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 288 participants (estimated)
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 16 Jan 2018 (actual)
- Primary completion
- 16 Jan 2020 (estimated)
- Study completion
- 16 Oct 2020 (estimated)
- First posted
- 26 Jul 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.
This is a multicenter, randomized, controlled trial to evaluate the efficacy and safety of Maintenance Treatment with Capecitabine plus Apatinib, Apatinib and Observation after First-line XELOX/SOX chemotherapy for Patients with Advanced Gastric Cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Maintenance Treatment Group A | Experimental | Drug: Apatinib+CapecitabineMaintenance Treatment with Capecitabine plus Apatinib after First-line XELOX chemotherapy for Patients with Advanced Gastric Cancer |
| Observation Group | No intervention | –Observation after First-line XELOX chemotherapy for Patients with Advanced Gastric Cancer |
| Maintenance Treatment Group B | Experimental | Drug: ApatinibMaintenance Treatment with Apatinib after First-line XELOX chemotherapy for Patients with Advanced Gastric Cancer |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- aged 18-75；
- had histologically confirmed unresectable and/or metastatic (primary or recurrent) adenocarcinoma of the stomach or gastroesophageal junction；
- received 4-6 cycles of Xelox/SOX regimens as first-line chemotherapy and the response was not progression disease (PD);
- ECOG 0-2；
- Patients were tested for tumor HER2 status before treatment, and patients with HER2-negative disease；
Key exclusion criteria (6 listed)
- previous radiotherapy to the abdomen；
- previous treatment for advanced disease (neoadjuvant chemotherapy was permitted if administered >6 months before enrollment)；
- pregnant or lactating women or women of childbearing potential；
- disease progression during the first-line chemotherapy;
- active gastrointestinal bleeding, arterial thrombosis or cerebrovascular accident within 6 months before enrollment
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 |
|---|---|---|
| Apatinib+CapecitabineAlso: apatinib, capecitabineCapecitabine 1000mg/m2 po bid, d1-14, Apatinib 250mg po Qd, Q21d | Drug | Maintenance Treatment Group A |
| ApatinibApatinib 250mg po Qd | Drug | Maintenance Treatment Group B |
Primary outcome
PFS
Time frame: 36 months
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
1 secondary outcome
OS
Time frame: 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2018.
- Individual participant dataSharing planned: Undecided
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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.
Xianglin Yuan, PhD,MD study chair
Tongji Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Apatinib+Capecitabine and Apatinib in people with Gastric Cancer, run by Huazhong University of Science and Technology 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 9 inclusion and 6 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 26 Jul 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Xianglin Yuan, PhD,MD (8627-83663406, xlyuan1020@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: 36 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 26 Jul 2018.