Stomach NeoplasmsPhase 3NCT03889626
The Maintenance Treatment of Apatinib/Capecitabine Versus Observation in Advanced Gastric Cancer
A Phase 3 study testing Apatinib and Capecitabine in people with Stomach Neoplasms and Gastrointestinal Neoplasms, run by Fudan University.
Trial summary
The purpose of this study is to evaluate the efficacy and tolerability of the maintenance treatment of Apatinib/Capecitabine after fluorouracil and platinum based first-line chemotherapy in advanced gastric cancer. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Stomach Neoplasms, Gastrointestinal Neoplasms, Stomach Diseases
- What is being tested?
- Apatinib and Capecitabine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 242 participants
- Where
- No sites listed yet
- Study dates
- 22 Mar 2019to 22 Mar 2024
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed advanced or metastatic gastric or gastroesophageal junction adenocarcinoma
- ECOG PS 0-2
- At least one measurable or evaluable lesion in the first-line chemotherapy
- The fist line treatment should be 5-FU based regimen (e.g. ECF/EOF/EOX/FOLFOX/XELOX/XP) , and patients should received 6 cycles (3-week regimen) or 12 cycles (2-week regimen) treatment with the efficacy of non-PD
- The time from the last cycle treatment to the enrollment cannot exceed 6 weeks
- Adequate hepatic, renal, heart, and hematologic functions (platelets ≥75×109/L, neutrophil ≥1.5×109/L, hemoglobin ≥80 g/L, serum creatinine ≤1.5mg/dl, total bilirubin ≤1.5mg/dl, and serum transaminase ≤2.5× the ULN)
Who cannot join
- Received 2 or more regimens for palliative chemotherapy
- Pregnant or lactating women
- Concurrent cancer, or history of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
- Uncontrolled brain, or leptomeningeal involvement, complete intestinal obstruction
- Clinically significant active bleeding, OB 2+ or higher
- Patients with locally advanced gastric cancer who are scheduled to receive radiotherapy
- Clinically relevant coronary artery disease or a history of a myocardial infarction within the last 12 months or high risk/uncontrolled arrhythmia
- Uncontrolled significant comorbid conditions
About this study
Official title: A Phase III Study of Comparing the Maintenance Treatment of Apatinib, Capecitabine and Observation After First-line Therapy in Advanced Gastric Cancer
The purpose of this study is to evaluate the efficacy and tolerability of the maintenance treatment of Apatinib/Capecitabine after fluorouracil and platinum based first-line chemotherapy in advanced gastric cancer.
Read the detailed description
Up to now, whether maintenance therapy after first line treatment can bring survival benefits to patients with advanced gastric cancer is unknown, and let alone which drug is most suitable. Our study is designed to prove whether the maintenance treatment of Apatinib or Capecitabine are better than observation after fluorouracil/platinum based first-line chemotherapy in advanced gastric cancer
- Conditions
- Stomach Neoplasms, Gastrointestinal Neoplasms, Stomach Diseases, Digestive System Neoplasms, Capecitabine, Apatinib
- Being tested
- Apatinib, Capecitabine
- Keywords
- Capecitabine, Apatinib, Maintenance Treatment, Advance Gastric Cancer
- Medical subject headings
- Stomach Neoplasms, Gastrointestinal Neoplasms, Stomach Diseases, Digestive System Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApatinibDrug
Apatinib: 500mg qd po, q4w
CapecitabineDrug
Capecitabine: 1000mg/m2 bid po, d1-14, q3w
| Study group | Role | What they receive |
|---|---|---|
| Apatinib | Experimental | In this arm, patients will receive a daily oral treatment with Apatinib 500mg. Receives: Drug: Apatinib |
| Capecitabine | Experimental | In this arm , patients will receive capecitabine 1000mg/m2 twice for 14 days, and repeat every 3 weeks. Receives: Drug: Capecitabine |
| Observation | No intervention | In this arm, no additional treatment will be given, and patients will be followed up at regular time |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS)
PFS is calculated from the time of randmization to disease progression or death whichever happen first
Measured: six weeks
Secondary outcomes (1)
Overall Survival (OS)
OS is calculated from the time of randmization to death
Measured: six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2019
- Study start22 Mar 2019 (estimated)
- Primary completion22 Mar 2022 (estimated)
- Study completion22 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stomach NeoplasmsStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe 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
- 242 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaodong Zhu, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03889626
- Sponsor's protocol ID
- Apa/Cap maintenance in GC
- Status last verified
- Mar 2019
- First submitted
- 17 Mar 2019
- Last updated
- 26 Mar 2019
- Results posted
- No
- Data monitoring committee
- 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 26 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Study of Comparing the Maintenance Treatment of Apatinib, Capecitabine and Observation After First-line Therapy in Advanced Gastric Cancer
- ClinicalTrials.gov ID
- NCT03889626
- Acronym / sponsor ID
- Apa/Cap maintenance in GC
- Conditions
- Stomach Neoplasms, Gastrointestinal Neoplasms, Stomach Diseases, Digestive System Neoplasms, Capecitabine, Apatinib
- Keywords
- Capecitabine, Apatinib, Maintenance Treatment, Advance Gastric Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 242 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 22 Mar 2019 (estimated)
- Primary completion
- 22 Mar 2022 (estimated)
- Study completion
- 22 Mar 2024 (estimated)
- First posted
- 26 Mar 2019 (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 is to evaluate the efficacy and tolerability of the maintenance treatment of Apatinib/Capecitabine after fluorouracil and platinum based first-line chemotherapy in advanced gastric cancer.
Detailed description
Up to now, whether maintenance therapy after first line treatment can bring survival benefits to patients with advanced gastric cancer is unknown, and let alone which drug is most suitable. Our study is designed to prove whether the maintenance treatment of Apatinib or Capecitabine are better than observation after fluorouracil/platinum based first-line chemotherapy in 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 |
|---|---|---|
| Apatinib | Experimental | Drug: ApatinibIn this arm, patients will receive a daily oral treatment with Apatinib 500mg. |
| Capecitabine | Experimental | Drug: CapecitabineIn this arm , patients will receive capecitabine 1000mg/m2 twice for 14 days, and repeat every 3 weeks. |
| Observation | No intervention | –In this arm, no additional treatment will be given, and patients will be followed up at regular time |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histologically confirmed advanced or metastatic gastric or gastroesophageal junction adenocarcinoma
- ECOG PS 0-2
- At least one measurable or evaluable lesion in the first-line chemotherapy
- The fist line treatment should be 5-FU based regimen (e.g. ECF/EOF/EOX/FOLFOX/XELOX/XP) , and patients should received 6 cycles (3-week regimen) or 12 cycles (2-week regimen) treatment with the efficacy of non-PD
- The time from the last cycle treatment to the enrollment cannot exceed 6 weeks
Key exclusion criteria (8 listed)
- Received 2 or more regimens for palliative chemotherapy
- Pregnant or lactating women
- Concurrent cancer, or history of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
- Uncontrolled brain, or leptomeningeal involvement, complete intestinal obstruction
- Clinically significant active bleeding, OB 2+ or higher
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 |
|---|---|---|
| ApatinibApatinib: 500mg qd po, q4w | Drug | Apatinib |
| CapecitabineCapecitabine: 1000mg/m2 bid po, d1-14, q3w | Drug | Capecitabine |
Primary outcome
Progression Free Survival (PFS)
Time frame: six weeks
PFS is calculated from the time of randmization to disease progression or death whichever happen first
1 secondary outcome
Overall Survival (OS)
Time frame: six weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2019.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Apatinib and Capecitabine in people with Stomach Neoplasms and Gastrointestinal Neoplasms, run by Fudan University.
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 6 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 26 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (PFS) (time frame: six weeks). 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 Mar 2019.