Malignant Neoplasm of Stomach Stage IIPhase 2NCT02697838
Clinical Trial of Apatinib Reverses Chemotherapy-Resistance of Patients With Advanced Gastric Cancer
A Phase 2 study testing Apatinib and Paclitaxel-based chemotherapeutic regimens in people with Malignant Neoplasm of Stomach Stage II, run by Fujian Cancer Hospital at 1 site in China.
Trial summary
A single arm study: Apatinib plus paclitaxel as the reverses treatment in advanced gastric cancer which paclitaxel-resistant. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Neoplasm of Stomach Stage II
- What is being tested?
- Apatinib and Paclitaxel-based chemotherapeutic regimens
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2016to 31 Oct 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: more than 18 years old;
- Histologically confirmed advanced or metastatic adenocarcinoma of gastric cancer(AGC) , including adenocarcinoma of the gastroesophageal junction;
- At least one measurable and evaluable disease based on response evaluation criteria in solid tumors (RECIST v1.1);
- The patient with Prior Paclitaxel-Resistant;
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-2;
- An expected survival of ≥ 3 months;
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- Duration from the last therapy is more than 6 weeks for nitroso or mitomycin, More than 4 weeks for other cytotoxic agents, operation or radiotherapy;
- Major organ function has to meet the following criteria; (1) For results of blood routine test:
- Hemoglobin (HB) ≥ 80g / L,
- ANC ≥ 1.5 × 109 / L,
- PLT ≥ 75 × 109 / L, (2) For results of biochemical tests:
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- BLT ≤ 1.25 times the upper limit of normal (ULN),
- ALT and AST ≤ 2.5 × ULN, liver metastases, if any, the ALT and AST≤ 5 × ULN,
- Serum Cr≤1ULN, Endogenous creatinine clearance rate >50ml/min;
- Pregnancy test (serum or urine) has to be performed for woman of childbearing age within 7 days before enrolment and the test result must be negative. They shall take appropriate methods for contraception during the study until the 8th week post the last administration of study drug. For men, (previous surgical sterilization accepted), shall agree to take appropriate methods of contraception during the study until the 8th week post the last administration of study drug;
- Patient has to voluntarily join the study and sign the Informed Consent Form for the study.
Who cannot join
- History of other malignancies except cured basal cell carcinoma of skin and carcinoma insitu of uterine cervix;
- Confirmed that apatinib and/or its accessories allergy;
- Subjects with poor-controlled arterial hypertension (systolic blood pressure> 140 mmHg and diastolic blood pressure > 90 mm Hg) despite standard medical management;
- Serious cardiovascular disease: Ⅱ-level myocardial ischemia or myocardial infarction, arrhythmia (including QT interval prolongation, for man ≥ 450 ms, for woman ≥ 470 ms); III ~ IV level cardiac function insufficiency, or echocardiography showed that left ventricular ejection fraction (LVEF < 50%);
- Patients with positive urinary protein (urine protein detection of 2 or more, or 24 hour urine protein >1.0g);
- Factors that could have an effect on oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction);
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- Subjects with high gastrointestinal bleeding risk, including the following conditions: local active ulcer lesions with positive fecal occult blood test (++); history of black stool, or vomiting blood in the past 2 months;unresected primary lesion in stomach with positive fecal occult blood test (+), ulcerated gastric carcinoma with massive alimentary tract bleeding risk judged by PIs based on gastric endoscopy result;
- Abnormal Coagulation (INR>1.5、APTT>1.5 UNL), with tendency of bleed;
- With psychotropic drug abuse history and can't get rid or with mental disorder patients;
- Less than 4 weeks from the last clinical trial;
- According to the researcher's judgment, with other serious diseases which harm to patient safety or affect patients complete the study;
- Evidence of central nervous system(CNS) metastasis;
- Pregnant or lactating women;
- Other conditions regimented at investigators' discretion.
Trial locations and contacts
1 site in 1 country.
About this study
A single arm study: Apatinib plus paclitaxel as the reverses treatment in advanced gastric cancer which paclitaxel-resistant.
Read the detailed description
This trial investigated the efficacy and safety of apatinib plus paclitaxel, as a treatment option for patients with advanced gastric cancer which paclitaxel-resistant.
- Conditions
- Malignant Neoplasm of Stomach Stage II
- Being tested
- Apatinib, Paclitaxel-based chemotherapeutic regimens
- 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
Apatinib (850 mg qd p.o.) until disease progression or intolerable toxicity or refused by the patients.
Paclitaxel-based chemotherapeutic regimensDrug
Paclitaxel-based chemotherapeutic regimens including:
- The POF regimen consisted of a 3-hour infusion of paclitaxel (135 mg/m2) followed by oxaliplatin (85 mg/m2) and Calcium Levofolinate (200 mg/m2).Subsequently, a 46-hour infusion of fluorouracil (2400 mg/m2) was administered using an ambulatory pump, repeating the cycle every 14 days.
- The PF regimen consisted of a 3-hour infusion of paclitaxel (135 mg/m2) followed by Calcium Levofolinate (200 mg/m2).Subsequently, a 46-hour infusion of fluorouracil (2400 mg/m2) was administered using an ambulatory pump, repeating the cycle every 14 days.
- Paclitaxel 80mg/m2 d1，d8，d15，repeating the cycle every 28 days
- other paclitaxel-based regimens
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Apatinib plus chemotherapy | Experimental | Not described Receives: Drug: Apatinib; Drug: Paclitaxel-based chemotherapeutic regimens |
What is being measured
The primary outcome is the main question the study is designed to answer.
disease control rate(DCR)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2016 (estimated)
- Study start1 Aug 2016
- Primary completion31 Mar 2018
- Study completion31 Oct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Malignant Neoplasm of Stomach Stage IIStudies of the same condition, open and under way.
- More trials run by Fujian Cancer 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fujian Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02697838
- Sponsor's protocol ID
- AHEAD-G323
- Status last verified
- Oct 2018
- First submitted
- 25 Feb 2016
- Last updated
- 17 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Zhao S, Fan N, Li H, Liu J, Huang F, Chen Y, Zhou M, Yu J, Lin R. Apatinib combined with paclitaxel-based chemotherapy in patients with taxane-resistant advanced gastric cancer: a single-arm exploratory study. Ann Transl Med. 2020 Oct;8(19):1233. doi: 10.21037/atm-20-5841.
PubMed 33178765
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial of Apatinib Reverses Chemotherapy-Resistance of Patients With Advanced Gastric Cancer
- ClinicalTrials.gov ID
- NCT02697838
- Acronym / sponsor ID
- AHEAD-G323
- Conditions
- Malignant Neoplasm of Stomach Stage II
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Fujian Cancer HospitalOther government
- Study start
- 1 Aug 2016 (actual)
- Primary completion
- 31 Mar 2018 (actual)
- Study completion
- 31 Oct 2018 (estimated)
- First posted
- 3 Mar 2016 (estimated)
- 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 arm study: Apatinib plus paclitaxel as the reverses treatment in advanced gastric cancer which paclitaxel-resistant.
Detailed description
This trial investigated the efficacy and safety of apatinib plus paclitaxel, as a treatment option for patients with advanced gastric cancer which paclitaxel-resistant.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: Apatinib plus chemotherapy | Experimental | Drug: Apatinib, Drug: Paclitaxel-based chemotherapeutic regimens |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Age: more than 18 years old;
- Histologically confirmed advanced or metastatic adenocarcinoma of gastric cancer(AGC) , including adenocarcinoma of the gastroesophageal junction;
- At least one measurable and evaluable disease based on response evaluation criteria in solid tumors (RECIST v1.1);
- The patient with Prior Paclitaxel-Resistant;
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-2;
Key exclusion criteria (14 listed)
- History of other malignancies except cured basal cell carcinoma of skin and carcinoma insitu of uterine cervix;
- Confirmed that apatinib and/or its accessories allergy;
- Subjects with poor-controlled arterial hypertension (systolic blood pressure> 140 mmHg and diastolic blood pressure > 90 mm Hg) despite standard medical management;
- Serious cardiovascular disease: Ⅱ-level myocardial ischemia or myocardial infarction, arrhythmia (including QT interval prolongation, for man ≥ 450 ms, for woman ≥ 470 ms); III ~ IV level cardiac function insufficiency, or echocardiography showed that left ventricular ejection fraction (LVEF < 50%);
- Patients with positive urinary protein (urine protein detection of 2 or more, or 24 hour urine protein >1.0g);
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 (850 mg qd p.o.) until disease progression or intolerable toxicity or refused by the patients. | Drug | Experimental: Apatinib plus chemotherapy |
| Paclitaxel-based chemotherapeutic regimensPaclitaxel-based chemotherapeutic regimens including: 1. The POF regimen consisted of a 3-hour infusion of paclitaxel (135 mg/m2) followed by oxaliplatin (85 mg/m2) and Calcium Levofolinate (200 mg/m2).Subsequently, a 46-hour infusion of fluorouracil (2400 mg/m2) was administered using an ambulatory pump, repeating the cycle every 14 days. 2. The PF regimen consisted of a 3-hour infusion of paclitaxel (135 mg/m2) followed by Calcium Levofolinate (200 mg/m2).Subsequently, a 46-hour infusion of fluorouracil (2400 mg/m2) was administered using an ambulatory pump, repeating the cycle every 14 days. 3. Paclitaxel 80mg/m2 d1，d8，d15，repeating the cycle every 28 days 4. other paclitaxel-based regimens | Drug | Experimental: Apatinib plus chemotherapy |
Primary outcome
disease control rate(DCR)
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2018.
- Derived from this study: PubMed 33178765Zhao S, Fan N, Li H, Liu J, Huang F, Chen Y, Zhou M, Yu J, Lin R. Apatinib combined with paclitaxel-based chemotherapy in patients with taxane-resistant advanced gastric cancer: a single-arm exploratory study. Ann Transl Med. 2020 Oct;8(19):1233. doi: 10.21037/atm-20-5841.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Paclitaxel-based chemotherapeutic regimens in people with Malignant Neoplasm of Stomach Stage II, run by Fujian Cancer 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 17 inclusion and 14 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 17 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?
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?
disease control rate(DCR) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02697838, which also lists 1 linked publication.
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 17 Oct 2018.