Gastric CancerPhase 2NCT02525237
Apatinib in Combination With S-1 as First-Line Treatment in Patients With Advanced Gastric Cancer
A Phase 2 study testing Apatinib and S-1 in people with Gastric Cancer, run by Qingdao Municipal Hospital.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of Apatinib combined with S-1 as first-line therapy for patients with advanced gastric or gastroesophageal junction adenocarcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Apatinib and S-1
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Aug 2015to Aug 2017
- 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
- Adult patients, aged ≥18 years;
- Histologically confirmed adenocarcinoma of the stomach with inoperable locally advanced or recurrent and/or metastatic disease;
- Measurable disease, according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1);
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 3;
- No previous chemotherapy for advanced/metastatic disease 1) Prior adjuvant/neoadjuvant therapy is allowed if at least 6 months has elapsed between completion of adjuvant/neoadjuvant therapy and enrolment into the study); 2) No previous targeted therapy; 3) For patients who can't tolerate first-line chemotherapy or refuse to accept chemotherapy, if they request to participate in this study, may receive apatinib monotherapy after consultation with the principal investigator in consideration of ethics.
- Hematological, Biochemical and Organ Functions: HB ≥ 80 g/L, ANC ≥ 1.5×109/L, PLT ≥ 80×109/L, BIL < 1.5×ULN, ALT or AST < 2.5×ULN (or < 5×ULN in patients with liver metastases), Serum Cr ≤ 1×ULN, Cr clearance ≥ 50 mL/min;
Show all 10Show fewer
- Life expectancy of more than 3 months;
- Duration from operation is more than 4 weeks;
- For women of child-bearing age, the pregnancy test results (serum or urine) within 7 days before enrolment must be negative. They will 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), will take appropriate methods for contraception during the study until the 8th week post the last administration of study drug.
- Signed informed consent.
Who cannot join
- Patients with poor-controlled arterial hypertension (systolic blood pressure > 140 mmHg or diastolic blood pressure > 90 mm Hg) despite standard medical management; Coronary heart disease, arrhythmia (including QT interval prolongation, for man > 450 ms, for woman > 470 ms), and cardiac dysfunction greater than Class II;
- Factors affecting the oral medication, such as inability to swallow, chronic diarrhea and intestinal obstruction;
- Patients with a clear tendency of gastrointestinal bleeding;
- Abnormal coagulation function (INR > 1.5×ULN, APTT > 1.5×ULN), with tendency of bleed;
- Pregnant or lactating women;
- Other conditions regimented at investigators' discretion.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Apatinib in Combination With S-1 as First-Line Treatment in Patients With Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
The purpose of this study is to evaluate the efficacy and safety of Apatinib combined with S-1 as first-line therapy for patients with advanced gastric or gastroesophageal junction adenocarcinoma.
- Conditions
- Gastric Cancer
- Being tested
- Apatinib, S-1
- 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 ATAN
Apatinib (500 mg qd p.o.) until disease progression or intolerable toxicity
S-1Drug
S-1 (40 mg/m2 qd days 1-14 q3w p.o.) until disease progression or intolerable toxicity
| Study group | Role | What they receive |
|---|---|---|
| Apatinib plus S-1 | Experimental | Apatinib (500 mg qd p.o.) concomitantly with S-1 (40 mg/m2 qd days 1-14 q3w p.o.) Receives: Drug: Apatinib; Drug: S-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival
Measured: Event driven, an expected average of 8 months
Safety will be assessed by incidence of adverse events
Measured: An expected average of 8 months
Secondary outcomes (4)
Objective response rate (ORR)
Measured: An expected average of 8 months
Disease control rate (DCR)
Measured: An expected average of 8 months
Overall survival (OS)
Measured: Event driven, an expected average of 24 months
Quality of life (QoL)
Quality of life of patient will be measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 [EORTC QLQ-C30].
Measured: An expected average of 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2015 (estimated)
- Study startAug 2015
- Primary completionAug 2016 (estimated)
- Study completionAug 2017 (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.
- 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qingdao Municipal Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
- Responsible party
- Principal investigator, Xiaochun Zhang, Qingdao Municipal Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02525237
- Sponsor's protocol ID
- Ahead-G316
- Status last verified
- Aug 2015
- First submitted
- 11 Aug 2015
- Last updated
- 17 Aug 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Apatinib in Combination With S-1 as First-Line Treatment in Patients With Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
- ClinicalTrials.gov ID
- NCT02525237
- Acronym / sponsor ID
- Ahead-G316
- Conditions
- Gastric Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Qingdao Municipal HospitalUniversity, hospital or other
- Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
- Study start
- Aug 2015
- Primary completion
- Aug 2016 (estimated)
- Study completion
- Aug 2017 (estimated)
- First posted
- 17 Aug 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 purpose of this study is to evaluate the efficacy and safety of Apatinib combined with S-1 as first-line therapy for patients with advanced gastric or gastroesophageal junction adenocarcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Apatinib plus S-1 | Experimental | Drug: Apatinib, Drug: S-1Apatinib (500 mg qd p.o.) concomitantly with S-1 (40 mg/m2 qd days 1-14 q3w p.o.) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Adult patients, aged ≥18 years;
- Histologically confirmed adenocarcinoma of the stomach with inoperable locally advanced or recurrent and/or metastatic disease;
- Measurable disease, according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1);
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 3;
- No previous chemotherapy for advanced/metastatic disease 1) Prior adjuvant/neoadjuvant therapy is allowed if at least 6 months has elapsed between completion of adjuvant/neoadjuvant therapy and enrolment into the study); 2) No previous targeted therapy; 3) For patients who can't tolerate first-line chemotherapy or refuse to accept chemotherapy, if they request to participate in this study, may receive apatinib monotherapy after consultation with the principal investigator in consideration of ethics.
Key exclusion criteria (6 listed)
- Patients with poor-controlled arterial hypertension (systolic blood pressure > 140 mmHg or diastolic blood pressure > 90 mm Hg) despite standard medical management; Coronary heart disease, arrhythmia (including QT interval prolongation, for man > 450 ms, for woman > 470 ms), and cardiac dysfunction greater than Class II;
- Factors affecting the oral medication, such as inability to swallow, chronic diarrhea and intestinal obstruction;
- Patients with a clear tendency of gastrointestinal bleeding;
- Abnormal coagulation function (INR > 1.5×ULN, APTT > 1.5×ULN), with tendency of bleed;
- Pregnant or lactating women;
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: ATANApatinib (500 mg qd p.o.) until disease progression or intolerable toxicity | Drug | Apatinib plus S-1 |
| S-1S-1 (40 mg/m2 qd days 1-14 q3w p.o.) until disease progression or intolerable toxicity | Drug | Apatinib plus S-1 |
Primary outcome
Progression Free Survival
Time frame: Event driven, an expected average of 8 months
Safety will be assessed by incidence of adverse events
Time frame: An expected average of 8 months
4 secondary outcomes
Objective response rate (ORR)
Time frame: An expected average of 8 months
Disease control rate (DCR)
Time frame: An expected average of 8 months
Overall survival (OS)
Time frame: Event driven, an expected average of 24 months
Quality of life (QoL)
Time frame: An expected average of 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2015.
Related trials for Gastric Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
Not yet recruitingPhase 1
GK01 Cell Therapy in Gastric Cancer With Peritoneal Metastasis
Gastric Cancer (GC)
RecruitingPhase 3
A Study of Neoadjuvant-adjuvant Durvalumab and FLOT Chemotherapy Followed by Adjuvant Durvalumab in Chinese Patients With Resectable GC/GEJC.
Gastric, Esophagogastric Junction
Active, not recruitingEarly Phase 1
Iomab-ACT: A Pilot Study of 131-I Apamistamab Followed by CD19-Targeted CAR T-Cell Therapy for Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia or Diffuse Large B-Cell Lymphoma
B-ALL, DLBCL
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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Apatinib and S-1 in people with Gastric Cancer, run by Qingdao Municipal Hospital.
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 10 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 17 Aug 2015. 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 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 Xiaochun Zhang, MD, PhD (+86 0532 88905767, zxc96701@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (time frame: Event driven, an expected average of 8 months). The study lists 2 primary outcomes in all. 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 17 Aug 2015.