Advanced Gastric or Gastroesophageal Junction AdenocarcinomaPhase 4NCT02426034
A Study of Apatinib Tablets in the Treatment of Advanced or Metastatic Gastric Cancer
A Phase 4 study testing ApatinibTablets in people with Advanced Gastric or Gastroesophageal Junction Adenocarcinoma, run by Jiangsu HengRui Medicine Co., Ltd. at 2 sites in China.
Trial summary
The large-scale phase IV study aims to verify the safety and efficacy of apatinib in patients with advanced gastric cancer or gastroesophageal junction adenocarcinoma after failure of two lines of chemotherapy. Apatinib initiated at a recommended dose of 850mg. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
- What is being tested?
- ApatinibTablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,004 participants
- Where
- 2 sitesChina
- Study dates
- 15 May 2015to 3 Sep 2020
- Phase
- Phase 4
- 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
- Age: 18 to75 years old;
- Pathologically diagnosed with advanced gastric cancer (including adenocarcinoma of the gastroesophageal junction);
- Failure of prior therapy (during or after treatment) in patients who have received at least two prior chemotherapy regimens;
- ECOG PS of 0-2;
- Major organ function has to meet the following criteria:
- For results of blood routine test (without blood transfusion within 14 days):
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- HB ≥ 90g / L ANC ≥ 1.5 × 109 / L PLT ≥ 80 × 109 / L
- Biochemical tests results:
- Bilirubin <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 ≤ 1 × ULN endogenous creatinine clearance>50ml/min (Cockcroft-Gault formula)
- An expected survival of ≥ 3 months;
- Patient received apatinib treatment regimen at investigators' discretion;
- Patient has to voluntarily join the study and sign the Informed Consent Form for the study;
- 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.
Who cannot join
- Subjects with uncontrolled arterial hypertension (systolic blood pressure> 140 mmHg and diastolic blood pressure > 90 mm Hg) despite standard medical management; Grade ≥ 2 coronary heart disease; Grade ≥ 2 arrhythmia (including QT interval prolongation, for man > 450 ms, for woman > 470 ms), as well as Grade ≥ 2 cardiac dysfunction;
- Factors that could have an effect on oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction);
- Subjects with high gastrointestinal bleeding risk, including the following conditions: presence of active ulceration combined with a positive fecal occult blood test (++);history of hematemesis and melena within three months before enrollment; 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 finding;
- Abnormal coagulation (INR>1.5、APTT>1.5 UNL), with tendency of bleeding;
- Presence of central nervous system metastases;
- Pregnant or lactating women;
- Other conditions regimented at investigators' discretion.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Nanjin Military 81 Hosiptal
Nanjing, Jiangsu
Fudan University cancer hospital
Shanghai, Shanghai Municipality, 200000
About this study
Official title: Safety and Efficacy of Apatinib in Patients With Advanced Gastric or Gastroesophageal Junction Adenocarcinoma After Failure of Two or More Lines of Chemotherapy (Ahead-G201): a Prospective, Single-arm, Multicenter, Phase IV Study
The large-scale phase IV study aims to verify the safety and efficacy of apatinib in patients with advanced gastric cancer or gastroesophageal junction adenocarcinoma after failure of two lines of chemotherapy. Apatinib initiated at a recommended dose of 850mg. However, the starting dose was decided by investigator's choice based on patients' condition. Dose interruption and dose reduction were allowed according to the product label. Treatment continued until disease progression, intolerable toxicity, withdrawal of informed consent, or at investigators' discretion. The primary endpoint was safety, which was assessed by recording the incidence and severity of adverse events.
- Being tested
- ApatinibTablets
- Keywords
- Advanced, Metastatic
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApatinibTabletsDrug
Apatinib Tablets, recommended dose of 850mg
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Apatinib Tablets Receives: Drug: ApatinibTablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety, which was assessed by recording the incidence and severity of adverse events
Measured: between first dose of apatinib and up to 30 days after the last dose of apatinib
Secondary outcomes (5)
Overall Survival
Measured: Event driven, an expected average of 34 weeks
Progression Free Survival
Measured: An expected average of 12 weeks
Objective Response Rate
Measured: An expected average of 12 weeks
Disease Control Rate
Measured: An expected average of 12 weeks
Quality of life, measured by the questionnaire of EORTC QLQ-C30
Measured: Quality of life will be assessed at baseline (after the patients provided written informed consent) until at least 4 weeks after the last dose of study drug was administered, an expected average of 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2015 (estimated)
- Study start15 May 2015
- Primary completion29 May 2020
- Study completion3 Sep 2020
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 Advanced Gastric or Gastroesophageal Junction AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A large-scale single-arm phase IV study
- Masking
- None (open label)
- Enrolment
- 2,004 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jin Li, MD, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02426034
- Sponsor's protocol ID
- Ahead-G201
- Status last verified
- Jun 2022
- First submitted
- 9 Apr 2015
- Last updated
- 1 Jul 2022
- Results posted
- No
- Individual data sharing
- Undecided
Publications
Li J, Qin S, Wen L, Wang J, Deng W, Guo W, Jia T, Jiang D, Zhang G, He Y, Ba Y, Zhong H, Wang L, Lin X, Yang J, Zhao J, Bai Y, Wu X, Gao F, Sun G, Wu Y, Ye F, Wang Q, Xie Z, Yi T, Huang Y, Yu G, Lu L, Yuan Y, Li W, Liu L, Sun Y, Sun Y, Yin L, Hou Z. Safety and efficacy of apatinib in patients with advanced gastric or gastroesophageal junction adenocarcinoma after the failure of two or more lines of chemotherapy (AHEAD): a prospective, single-arm, multicenter, phase IV study. BMC Med. 2023 May 5;21(1):173. doi: 10.1186/s12916-023-02841-7.
PubMed 37147645
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Apatinib in Patients With Advanced Gastric or Gastroesophageal Junction Adenocarcinoma After Failure of Two or More Lines of Chemotherapy (Ahead-G201): a Prospective, Single-arm, Multicenter, Phase IV Study
- ClinicalTrials.gov ID
- NCT02426034
- Acronym / sponsor ID
- Ahead-G201
- Keywords
- Advanced, Metastatic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,004 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 May 2015 (actual)
- Primary completion
- 29 May 2020 (actual)
- Study completion
- 3 Sep 2020 (actual)
- First posted
- 24 Apr 2015 (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.
The large-scale phase IV study aims to verify the safety and efficacy of apatinib in patients with advanced gastric cancer or gastroesophageal junction adenocarcinoma after failure of two lines of chemotherapy. Apatinib initiated at a recommended dose of 850mg. However, the starting dose was decided by investigator's choice based on patients' condition. Dose interruption and dose reduction were allowed according to the product label. Treatment continued until disease progression, intolerable toxicity, withdrawal of informed consent, or at investigators' discretion. The primary endpoint was safety, which was assessed by recording the incidence and severity of adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A large-scale single-arm phase IV study
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Drug: ApatinibTabletsApatinib Tablets |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Age: 18 to75 years old;
- Pathologically diagnosed with advanced gastric cancer (including adenocarcinoma of the gastroesophageal junction);
- Failure of prior therapy (during or after treatment) in patients who have received at least two prior chemotherapy regimens;
- ECOG PS of 0-2;
- Major organ function has to meet the following criteria:
Key exclusion criteria (7 listed)
- Subjects with uncontrolled arterial hypertension (systolic blood pressure> 140 mmHg and diastolic blood pressure > 90 mm Hg) despite standard medical management; Grade ≥ 2 coronary heart disease; Grade ≥ 2 arrhythmia (including QT interval prolongation, for man > 450 ms, for woman > 470 ms), as well as Grade ≥ 2 cardiac dysfunction;
- Factors that could have an effect on oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction);
- Subjects with high gastrointestinal bleeding risk, including the following conditions: presence of active ulceration combined with a positive fecal occult blood test (++);history of hematemesis and melena within three months before enrollment; 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 finding;
- Abnormal coagulation (INR>1.5、APTT>1.5 UNL), with tendency of bleeding;
- Presence of central nervous system metastases;
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 |
|---|---|---|
| ApatinibTabletsApatinib Tablets, recommended dose of 850mg | Drug | Treatment group |
Primary outcome
Safety, which was assessed by recording the incidence and severity of adverse events
Time frame: between first dose of apatinib and up to 30 days after the last dose of apatinib
5 secondary outcomes
Overall Survival
Time frame: Event driven, an expected average of 34 weeks
Progression Free Survival
Time frame: An expected average of 12 weeks
Objective Response Rate
Time frame: An expected average of 12 weeks
Disease Control Rate
Time frame: An expected average of 12 weeks
Quality of life, measured by the questionnaire of EORTC QLQ-C30
Time frame: Quality of life will be assessed at baseline (after the patients provided written informed consent) until at least 4 weeks after the last dose of study drug was administered, an expected average of 14 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2022.
- Derived from this study: PubMed 37147645Li J, Qin S, Wen L, Wang J, Deng W, Guo W, Jia T, Jiang D, Zhang G, He Y, Ba Y, Zhong H, Wang L, Lin X, Yang J, Zhao J, Bai Y, Wu X, Gao F, Sun G, Wu Y, Ye F, Wang Q, Xie Z, Yi T, Huang Y, Yu G, Lu L, Yuan Y, Li W, Liu L, Sun Y, Sun Y, Yin L, Hou Z. Safety and efficacy of apatinib in patients with advanced gastric or gastroesophageal junction adenocarcinoma after the failure of two or more lines of chemotherapy (AHEAD): a prospective, single-arm, multicenter, phase IV study. BMC Med. 2023 May 5;21(1):173. doi: 10.1186/s12916-023-02841-7.
- 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.
Jin Li, MD principal investigator
Fudan University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ApatinibTablets in people with Advanced Gastric or Gastroesophageal Junction Adenocarcinoma, run by Jiangsu HengRui Medicine Co., Ltd. at 2 sites 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 13 inclusion and 7 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: finished, as of the sponsor's last update on 1 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Safety, which was assessed by recording the incidence and severity of adverse events (time frame: between first dose of apatinib and up to 30 days after the last dose of apatinib). 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 NCT02426034, 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 1 Jul 2022.