Gastric CarcinomaPhase 1/2NCT03599778
XELOX Combined With Apatinib as Post-operative Chemotherapy in Locally Advanced Gastric Adenocarcinoma
A Phase 1/2 study testing Apatinib in people with Gastric Carcinoma, run by Anhui Provincial Hospital at 1 site in China.
Trial summary
To observe and evaluate the efficacy and safety of oxaliplatin with oapecitabine（XELOX）combined with apatinib as post-operative chemotherapy in locally advanced gastric adenocarcinoma with D2 dissection Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Gastric Carcinoma
- What is being tested?
- Apatinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2018to 30 Jan 2025
- Phase
- Phase 1/2
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ECOG score is 0-1;
- Radical gastrectomy (D2, R0) for gastric cancer has been performed (more than 16 lymph nodes have been detected);
- Postoperative histology confirmed gastric adenocarcinoma；
- The pathological stage of gastric cancer is ⅢA-ⅢC stage (8th AJCC TNM);
- Subjects' baseline blood routine and biochemical indicators meet the following standards:
- ANC≥1.5×109/L;
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- Hb≥90g/L;
- PLT≥100×109/L;
- TBIL≤1.5×ULN;
- ALT and AST≤2×ULN;
- Cr≤1.5×ULN
- INR：1.0～1.5; APTT is within the normal range
- The electrocardiogram was basically normal before the first 4 weeks after admission, and there were no obvious clinical symptoms of heart disease;
- Sign informed consent.
Who cannot join
- Patients with severe hypertension and poor drug control;
- Various factors that affect oral drugs such as (inability to swallow, complete or incomplete gastrointestinal obstruction, active gastrointestinal bleeding, perforation ) ;
- Patients with previous bradycardia or prolonged QT interval;
- Patients with postoperative gastrointestinal fistula and wound rupture;
- Known allergy to capecitabine or oxaliplatin, or metabolic disorder;
- Patients receiving preoperative chemotherapy, radiotherapy or targeted therapy before;
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- Patients Using other experimental drugs at the same time or joining in other clinical trials.
- Patients with severe liver diseases (such as liver cirrhosis), nephropathy, respiratory diseases or chronic systemic diseases such as uncontrollable diabetes and hypertension; Clinical symptoms of heart disease,such as congestive heart failure,coronary heart disease symptoms, arrhythmia, hypertension,that hard to control,or having myocardial infarction attack in six months or cardiac insufficiency.
- Patients with peripheral nervous system disorder or with a history of significant psychiatric disorder and central nervous system disorder;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I/II Clinical Study to Compare Postoperative Chemotherapy of Oxaliplatin With Capecitabine（XELOX）Combined With APATINIB as Post-operative Chemotherapy in Locally Advanced Gastric Adenocarcinoma With D2 Dissection
To observe and evaluate the efficacy and safety of oxaliplatin with oapecitabine（XELOX）combined with apatinib as post-operative chemotherapy in locally advanced gastric adenocarcinoma with D2 dissection
Read the detailed description
Stage 1 (phase I tolerance study) : 12 patients were enrolled in the dose-climbing study:According to the principle of dose-climbing test,todetermine the subjects' MTD, with the following three dose levels:
- Capecitabine: 1000 mg/m2 bid d1-14 q3w, oxaliplatin: 130 mg/m2 d1 q3w) + apatinib 250 mg, qd x180d; ②. Capecitabine: 1000 mg/m2 bid d1-14 q3w, oxaliplatin: 130 mg/m2 d1 q3w) + apatinib 375 mg, qd x180d; ③. Capecitabine: 1000 mg/m2 bid d1-14 q3w, oxaliplatin: 130 mg/m2 d1 q3w) + apatinib 500 mg, qd x180d;
Stage 2 (phase II exploratory study) :
①.Test group: subjects received 8 cycles of postoperative XELOX regimen (capecitabine: 1000 mg/m2 bid d1-14 q3w, oxaliplatin: 130 mg/m2 d1 q3w) + apatinib maximum tolerated dose
②.Control group: Subjects received 8 cycles of XELOX regimen after surgery (capecitabine: 1000 mg/m2 bid d1-14 q3w, oxaliplatin: 130 mg/m2 d1 q3w).
Eligible patients will receive 8 cycles of postoperative adjuvant therapy and will be followed up to death
- Conditions
- Gastric Carcinoma
- Being tested
- Apatinib
- Keywords
- apatinib, Gastric Carcinoma, post-operative chemotherapy
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApatinibDrug
Also called XELOX
XELOX + apatinib's MTD
| Study group | Role | What they receive |
|---|---|---|
| treatment group | Experimental | 8 cycles of postoperative XELOX regimen (capecitabine: 1000 mg/m2 bid d1-14 q3w, oxaliplatin: 130 mg/m2 d1 q3w) + apatinib'MTD(maximum tolerated dose) Receives: Drug: Apatinib |
| Control group | Active comparator | 8 cycles of postoperative XELOX regimen (capecitabine: 1000 mg/m2 bid d1-14 q3w, oxaliplatin: 130 mg/m2 d1 q3w) Receives: Drug: Apatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free survival (DFS)
Disease-free survival (DFS) is defined as the time from the beginning of treatment to Disease recurrence or death due to Disease progression
Measured: 3 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 start1 Sep 2018 (estimated)
- Primary completion30 Jan 2025 (estimated)
- Study completion30 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CarcinomaStudies of the same condition, open and under way.
- More trials run by Anhui Provincial HospitalThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anhui Provincial Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Xinyang He, master, Principal investigator, Anhui Provincial Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03599778
- Sponsor's protocol ID
- AHTH-201
- Status last verified
- Jul 2018
- First submitted
- 14 Jun 2018
- Last updated
- 26 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
- A Phase I/II Clinical Study to Compare Postoperative Chemotherapy of Oxaliplatin With Capecitabine（XELOX）Combined With APATINIB as Post-operative Chemotherapy in Locally Advanced Gastric Adenocarcinoma With D2 Dissection
- ClinicalTrials.gov ID
- NCT03599778
- Acronym / sponsor ID
- AHTH-201
- Conditions
- Gastric Carcinoma
- Keywords
- apatinib, Gastric Carcinoma, post-operative chemotherapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Anhui Provincial HospitalOther government
- Study start
- 1 Sep 2018 (estimated)
- Primary completion
- 30 Jan 2025 (estimated)
- Study completion
- 30 Jan 2025 (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.
To observe and evaluate the efficacy and safety of oxaliplatin with oapecitabine（XELOX）combined with apatinib as post-operative chemotherapy in locally advanced gastric adenocarcinoma with D2 dissection
Detailed description
Stage 1 (phase I tolerance study) : 12 patients were enrolled in the dose-climbing study:According to the principle of dose-climbing test,todetermine the subjects' MTD, with the following three dose levels:
- Capecitabine: 1000 mg/m2 bid d1-14 q3w, oxaliplatin: 130 mg/m2 d1 q3w) + apatinib 250 mg, qd x180d; ②. Capecitabine: 1000 mg/m2 bid d1-14 q3w, oxaliplatin: 130 mg/m2 d1 q3w) + apatinib 375 mg, qd x180d; ③. Capecitabine: 1000 mg/m2 bid d1-14 q3w, oxaliplatin: 130 mg/m2 d1 q3w) + apatinib 500 mg, qd x180d;
Stage 2 (phase II exploratory study) :
①.Test group: subjects received 8 cycles of postoperative XELOX regimen (capecitabine: 1000 mg/m2 bid d1-14 q3w, oxaliplatin: 130 mg/m2 d1 q3w) + apatinib maximum tolerated dose
②.Control group: Subjects received 8 cycles of XELOX regimen after surgery (capecitabine: 1000 mg/m2 bid d1-14 q3w, oxaliplatin: 130 mg/m2 d1 q3w).
Eligible patients will receive 8 cycles of postoperative adjuvant therapy and will be followed up to death
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| treatment group | Experimental | Drug: Apatinib8 cycles of postoperative XELOX regimen (capecitabine: 1000 mg/m2 bid d1-14 q3w, oxaliplatin: 130 mg/m2 d1 q3w) + apatinib'MTD(maximum tolerated dose) |
| Control group | Active comparator | Drug: Apatinib8 cycles of postoperative XELOX regimen (capecitabine: 1000 mg/m2 bid d1-14 q3w, oxaliplatin: 130 mg/m2 d1 q3w) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- ECOG score is 0-1;
- Radical gastrectomy (D2, R0) for gastric cancer has been performed (more than 16 lymph nodes have been detected);
- Postoperative histology confirmed gastric adenocarcinoma；
- The pathological stage of gastric cancer is ⅢA-ⅢC stage (8th AJCC TNM);
- Subjects' baseline blood routine and biochemical indicators meet the following standards:
Key exclusion criteria (9 listed)
- Patients with severe hypertension and poor drug control;
- Various factors that affect oral drugs such as (inability to swallow, complete or incomplete gastrointestinal obstruction, active gastrointestinal bleeding, perforation ) ;
- Patients with previous bradycardia or prolonged QT interval;
- Patients with postoperative gastrointestinal fistula and wound rupture;
- Known allergy to capecitabine or oxaliplatin, or metabolic 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 |
|---|---|---|
| ApatinibAlso: XELOXXELOX + apatinib's MTD | Drug | Control group, treatment group |
Primary outcome
Disease-free survival (DFS)
Time frame: 3 months
Disease-free survival (DFS) is defined as the time from the beginning of treatment to Disease recurrence or death due to Disease progression
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.
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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.
Xinyang He, master principal investigator
Anhui Provincial Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Apatinib in people with Gastric Carcinoma, run by Anhui Provincial 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 14 inclusion and 9 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Xinyang He, master (13505518319, HXY2333@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-free survival (DFS) (time frame: 3 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.