Gastric CarcinomaPhase 3NCT03355612
XELOX Plus Apatinib vs XELOX as Post-operative Chemotherapy in Locally Advanced Gastric Signet Ring Carcinoma
A Phase 3 study testing Apatinib and XELOX in people with Gastric Carcinoma, run by Tianjin Medical University Cancer Institute and Hospital.
Trial summary
This is a randomized, multicenter, controlled study to compared the Efficacy and Safety of XELOX combined with Apatinib versus XELOX as post-operative chemotherapy in locally advanced gastric signet ring carcinoma 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 and XELOX
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 456 participants
- Where
- No sites listed yet
- Study dates
- 20 Dec 2017to 20 Dec 2025
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. ≥ 18 and ≤ 70 years of age;
- 2. Eastern Cooperative Oncology Group Performance Status: 0-1;
- 3. Had been treated with Radical resection (D2, R0) of gastric cancer (Lymph node≥16);
- 4. Postoperative histological proven gastric signet-ring cell carcinoma(or contains signet-ring cell carcinoma);
- 5. Pathological stage:IIIA-IIIC（8th AJCC TNM）;
- 6. Patients have adequate baseline organ and marrow function :hemoglobin≥9g/dL; absolute neutrophil count (ANC) ≥1,500/mm3; PLT(platelets)≥1000,000/mm3; total bilirubin ≤1.5×upper normal limit(ULN); AST ≤2.5 ×ULN, ALT ≤2.5 ×ULN; prothrombin time-international normalized ratio≤1.5, and APTT(activated partial thromboplastin time) was within normal range; creatine ≤ 1.5 x ULN;
- 7. The ECG(electrocardiography) was basically normal in the 4 weeks before the study, and there was no obvious clinical symptoms of heart disease;
- 8. sign informed consent.
Who cannot join
- 1. Patients with hypertension and uncontrolled hypertension with hypotensive drugs therapy ;
- 2. Patients with dysphagia, complete or incomplete digestive tract obstruction, gastrointestinal bleeding, perforation, etc;
- 3. Patients had bradycardia or a QT extension;
- 4. Patients had gastrointestinal fistula and lacerations after surgery;
- 5. Allergic to capecitabine or oxaliplatin, or metabolic disorders;
- 6. Patients accepted Preoperative chemotherapy, radiotherapy or targeted therapy;
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- 7. Attending other drug clinical trials;
- 8. Patients with Serious liver disease (such as cirrhosis, etc.), kidney disease, respiratory disease or uncontrolled diabetes, hypertension and other chronic systemic diseases, heart disease with Clinical symptoms（such as congestive heart failure, coronary heart disease symptoms, drug is difficult to control arrhythmia, hypertension, or six months had a myocardial infarction attack, or cardiac insufficiency）;
- 9. Patients with peripheral nervous system disorder or apparent mental disorders or had the history of central nervous system disorders;
- 10. Patients with serious infection(above CTCAE grade 2);
- 11. Patient with history of another malignant cancer within past 5 years（not including: cervical carcinoma in situ, non melanoma skin cancer and superficial bladder tumor );
- 12. Have the history of organ transplantation, Or have received systemic steroid therapy for a long time (note: short term user stopping medication >2 weeks can be included);
- 13. Pregnant or lactating women, women of child-bearing potential, unwilling to use adequate contraceptive protection during the process of the study;
- 14. Patients without legal capacity,or medical/ethical reasons may influence the study to continue.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Randomized, Multicenter, Controlled Study of XELOX (Oxaliplatin With Capecitabine) Combined With Apatinib Versus XELOX as Post-operative Chemotherapy in Locally Advanced Gastric Signet Ring Carcinoma With D2 Dissection.
This is a randomized, multicenter, controlled study to compared the Efficacy and Safety of XELOX combined with Apatinib versus XELOX as post-operative chemotherapy in locally advanced gastric signet ring carcinoma with D2 dissection.
Read the detailed description
The purpose of this study is to prove that as for disease free survival time, and safety, Apatinib with XELOX(Oxaliplatin with Capecitabine) has a better effect over that of XELOX adjunct therapy group for postoperative chemotherapy of locally advanced gastric signet ring carcinoma with D2 dissection.
- Conditions
- Gastric Carcinoma
- Being tested
- Apatinib, XELOX
- 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 YN968D1
Apatinib: 500 mg, qd, po, last 180 days
XELOXDrug
Also called Capecitabine and Oxaliplatin
Capecitabine:1000 mg/m2 bid d1-14 q3w, Oxaliplatin:130 mg/m2 d1 q3w
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | Drug:Apatinib with XELOX(Capecitabine and Oxaliplatin) Receives: Drug: Apatinib; Drug: XELOX |
| active comparator | Active comparator | Drug:XELOX(Capecitabine and Oxaliplatin) Receives: Drug: XELOX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease Free Survival(DFS)
Disease Free Survivalof the Participants
Measured: 5 years
Secondary outcomes (2)
Overall Survival(OS)
Overall Survival of the Participants
Measured: 8 years
Percentage of Participants With Adverse Events
Percentage of Participants With Adverse Events
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2017
- Study start20 Dec 2017 (estimated)
- Primary completion20 Dec 2020 (estimated)
- Study completion20 Dec 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 Tianjin Medical University Cancer Institute and 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 456 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Han Liang, Master, Study chair, Tianjin Medical University Cancer Institute and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03355612
- Sponsor's protocol ID
- RESAPAS Trial
- Status last verified
- Nov 2017
- First submitted
- 22 Nov 2017
- Last updated
- 28 Nov 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multicenter, Controlled Study of XELOX (Oxaliplatin With Capecitabine) Combined With Apatinib Versus XELOX as Post-operative Chemotherapy in Locally Advanced Gastric Signet Ring Carcinoma With D2 Dissection.
- ClinicalTrials.gov ID
- NCT03355612
- Acronym / sponsor ID
- RESAPAS Trial
- Conditions
- Gastric Carcinoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 456 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 20 Dec 2017 (estimated)
- Primary completion
- 20 Dec 2020 (estimated)
- Study completion
- 20 Dec 2025 (estimated)
- First posted
- 28 Nov 2017 (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.
This is a randomized, multicenter, controlled study to compared the Efficacy and Safety of XELOX combined with Apatinib versus XELOX as post-operative chemotherapy in locally advanced gastric signet ring carcinoma with D2 dissection.
Detailed description
The purpose of this study is to prove that as for disease free survival time, and safety, Apatinib with XELOX(Oxaliplatin with Capecitabine) has a better effect over that of XELOX adjunct therapy group for postoperative chemotherapy of locally advanced gastric signet ring carcinoma with D2 dissection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Drug: Apatinib, Drug: XELOXDrug:Apatinib with XELOX(Capecitabine and Oxaliplatin) |
| active comparator | Active comparator | Drug: XELOXDrug:XELOX(Capecitabine and Oxaliplatin) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 1. ≥ 18 and ≤ 70 years of age;
- 2. Eastern Cooperative Oncology Group Performance Status: 0-1;
- 3. Had been treated with Radical resection (D2, R0) of gastric cancer (Lymph node≥16);
- 4. Postoperative histological proven gastric signet-ring cell carcinoma(or contains signet-ring cell carcinoma);
- 5. Pathological stage:IIIA-IIIC（8th AJCC TNM）;
Key exclusion criteria (14 listed)
- 1. Patients with hypertension and uncontrolled hypertension with hypotensive drugs therapy ;
- 2. Patients with dysphagia, complete or incomplete digestive tract obstruction, gastrointestinal bleeding, perforation, etc;
- 3. Patients had bradycardia or a QT extension;
- 4. Patients had gastrointestinal fistula and lacerations after surgery;
- 5. Allergic to capecitabine or oxaliplatin, or metabolic disorders;
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: YN968D1Apatinib: 500 mg, qd, po, last 180 days | Drug | experimental group |
| XELOXAlso: Capecitabine and OxaliplatinCapecitabine:1000 mg/m2 bid d1-14 q3w, Oxaliplatin:130 mg/m2 d1 q3w | Drug | active comparator, experimental group |
Primary outcome
Disease Free Survival(DFS)
Time frame: 5 years
Disease Free Survivalof the Participants
2 secondary outcomes
Overall Survival(OS)
Time frame: 8 years
Percentage of Participants With Adverse Events
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2017.
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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.
Han Liang, Master study chair
Tianjin Medical University Cancer Institute and Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Apatinib and XELOX in people with Gastric Carcinoma, run by Tianjin Medical University Cancer Institute and 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 8 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 28 Nov 2017. 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?
Contact Han Liang, Master (（022）23340123 ext. 1063, tjlianghan@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: 5 years). 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 28 Nov 2017.