Gastric CancerPhase 2NCT02529878
Study of Convernsion Therapy Using S1/Paclitaxel Chemotherapy Plus Apatinib in Unresectable Gastric Cancer
A Phase 2 study testing S1/Paclitaxel chemotherapy plus Apatinib in people with Gastric Cancer, run by The First Affiliated Hospital of Zhejiang Chinese Medical University at 1 site in China.
Trial summary
The prognosis of metastatic gastric cancer is poor. Chemotherapy occasionally converts an initially unresectable gastric cancer to a resectable cancer. Previous studies showed patients with unresectable gastric cancer may obtain a survival benefit from chemotherapy and subsequent curative surgery. Read more about this study
- Who is it for?
- Ages 20 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- S1/Paclitaxel chemotherapy plus Apatinib
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- Aug 2015to Aug 2019
- 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 20 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- unresectable gastric cancer as proven histologically(AJCC, version 7) under any following condition: unable radical excision due to the local metastasis of invasion metastasis to the lymph node beside the abdominal aorta, non-extensive metastasis to liver( not more than three metastatic foci of radical excision), Peritoneal metastasis(CY1,P1,P2), kukerburg tumor
- Definitely diagnosed as above stage of gastric cancer before operation via CT of MRI, ultrasonic endoscopy, PET-CT, or through the laparoscopic exploration if necessary
- Untreated(e.g. radiotherapy, chemotherapy, target therapy and immunotherapy)
- Negative HER-2 state
- ECOG(Eastern Cooperative Oncology Group) :0~2
- Age: 18~75 years old
Show all 11Show fewer
- Normal hemodynamic indices before the recruitment(including blood cell count and liver/kidney function ). For example: WBC>4.0*109/L, NE>1.5*109/L, PLT>100*109/L, BIL<1.5 times of upper limit of normal reference value, ALT and AST<2.5 times of upper limit of normal reference value, and CRE<1.2mg/dl
- Good cardiac function before the recruitment, no seizure of myocardial infarction in past half years, and controllable hypertension and other coronary heart disease
- Not concomitant with other uncontrollable benign disease before the recruitment(e.g. the infection in the kidney, lung and liver)
- Not participating in other clinical trials before and during the treatment
- Signed the Informed Consent Form
Who cannot join
- not conforming above inclusion conditions
- Distal metastasis to lung, brain, and bone
- Ever operation on the stomach
- Operation intolerance due to other systemic basic disease
- Ever administrated with other drugs(including TCM drugs) before the recruitment, or no guarantee of progress according to the study requirement after recruitment
- Allergy to the drugs in this protocol
- Pregnant and lactating women
- Women at childbearing age and of pregnancy desire during the study
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
the First Affiliated Hospital of Zhejiang Chinese Medical University
Hangzhou, Zhejiang, 310006
Xiangdong Cheng, MD, +86-057187970965, getfar@foxmail.com
About this study
Official title: A Prospective Feasibility Study for Convernsion Therapy Using S1/Paclitaxel Chemotherapy Plus Apatinib in Unresectable Gastric Cancer
The prognosis of metastatic gastric cancer is poor. Chemotherapy occasionally converts an initially unresectable gastric cancer to a resectable cancer. Previous studies showed patients with unresectable gastric cancer may obtain a survival benefit from chemotherapy and subsequent curative surgery. The key of conversion therapy of initially unresectable metastatic GC is the high response rate. Apatinib, a novel targeted inhibitor of VEGF receptor 2 (VEGFR2), shows significant antitumor activity in the patients with GC. The purpose of this study is to investigate the efficacy and safety of S1/Paclitaxel chemotherapy plus Apatinib in the conversion therapys of metastatic gastric cancer.
Read the detailed description
The investigators will apply SPA regimen for coversional therapy to abtain high response rate.
Paclitaxel：150 mg/m2 i.v.3h , given on the first day. Apatinib, oral ,initial dose :500mg, QD, after meal ( try to take the medicine at the same time of the day ).
Dose adjustment: Down-regulate the dosage to 250 mg per day at the first time. If the patient totally recovers from the toxic reaction after the regulation, we could up-regulate the dosage back to the former level. If the down-regulation occurs again according to the protocol , then the up-regulation will be forbidden.
S-1 dosage: According to the body surface area, the initial dosage of S-1 is decided by the following criteria. Take the medicine twice daily (after breakfast and supper) for 2 weeks, then suspend for 1 week.
Preventive medication: To prevent serious allergic reaction of Paclitaxel, preventive medication should be given in advance. We usually give dexamethasone 20mg orally 12 and 6 hours before the Paclitaxel, and diphenhydramine (or something analogous) 50 mg, cimetidine 300mg (or ranitidine 50mg) I.V. 30-60 minutes before the Paclitaxel.
Repeat the therapeutic schedule every 3 weeks. 3 cycles of neoadjuvant chemotherapy before surgery, stop Apatinib in the last cycle.
3 cycles of adjuvant chemotherapy including S-1 and Apatinib 4 to 6 weeks after surgery.
- Conditions
- Gastric Cancer
- Being tested
- S1/Paclitaxel chemotherapy plus Apatinib
- Keywords
- gastric caner, Apatinib, S1, conversion therapy, metastatic gastric cancer
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S1/Paclitaxel chemotherapy plus ApatinibDrug
Also called SPA
S1:60mg twice daily(after the breakfast and supper) for two weeks, and then suspend for one week Paclitaxel:150mg/m2,iv, 3h, at day1 Apatinib:500mg once daily
| Study group | Role | What they receive |
|---|---|---|
| conversion treatment | Experimental | after 3 cycles S1/Paclitaxel chemotherapy plus Apatinib,subsequent surgery will be conducted with curative intent Receives: Drug: S1/Paclitaxel chemotherapy plus Apatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
radical resection rate
the radical resection rates
Measured: 4 months
Secondary outcomes (3)
overall survival
the overall survival time
Measured: 3 years
adverse events
number and degree of adverse events
Measured: 6 months
reaction rate
the reaction rate of chemotherapy
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2015 (estimated)
- Study startAug 2015
- Primary completionAug 2016 (estimated)
- Study completionAug 2019 (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
- The First Affiliated Hospital of Zhejiang Chinese Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Xiangdong Cheng, MD, Principal investigator, The First Affiliated Hospital of Zhejiang Chinese Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02529878
- Sponsor's protocol ID
- ECGC-0001
- Status last verified
- Feb 2016
- First submitted
- 19 Aug 2015
- Last updated
- 26 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Feasibility Study for Convernsion Therapy Using S1/Paclitaxel Chemotherapy Plus Apatinib in Unresectable Gastric Cancer
- ClinicalTrials.gov ID
- NCT02529878
- Acronym / sponsor ID
- ECGC-0001
- Conditions
- Gastric Cancer
- Keywords
- gastric caner, Apatinib, S1, conversion therapy, metastatic gastric cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Zhejiang Chinese Medical UniversityUniversity, hospital or other
- Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
- Study start
- Aug 2015
- Primary completion
- Aug 2016 (estimated)
- Study completion
- Aug 2019 (estimated)
- First posted
- 20 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 prognosis of metastatic gastric cancer is poor. Chemotherapy occasionally converts an initially unresectable gastric cancer to a resectable cancer. Previous studies showed patients with unresectable gastric cancer may obtain a survival benefit from chemotherapy and subsequent curative surgery. The key of conversion therapy of initially unresectable metastatic GC is the high response rate. Apatinib, a novel targeted inhibitor of VEGF receptor 2 (VEGFR2), shows significant antitumor activity in the patients with GC. The purpose of this study is to investigate the efficacy and safety of S1/Paclitaxel chemotherapy plus Apatinib in the conversion therapys of metastatic gastric cancer.
Detailed description
The investigators will apply SPA regimen for coversional therapy to abtain high response rate.
Paclitaxel：150 mg/m2 i.v.3h , given on the first day. Apatinib, oral ,initial dose :500mg, QD, after meal ( try to take the medicine at the same time of the day ).
Dose adjustment: Down-regulate the dosage to 250 mg per day at the first time. If the patient totally recovers from the toxic reaction after the regulation, we could up-regulate the dosage back to the former level. If the down-regulation occurs again according to the protocol , then the up-regulation will be forbidden.
S-1 dosage: According to the body surface area, the initial dosage of S-1 is decided by the following criteria. Take the medicine twice daily (after breakfast and supper) for 2 weeks, then suspend for 1 week.
Preventive medication: To prevent serious allergic reaction of Paclitaxel, preventive medication should be given in advance. We usually give dexamethasone 20mg orally 12 and 6 hours before the Paclitaxel, and diphenhydramine (or something analogous) 50 mg, cimetidine 300mg (or ranitidine 50mg) I.V. 30-60 minutes before the Paclitaxel.
Repeat the therapeutic schedule every 3 weeks. 3 cycles of neoadjuvant chemotherapy before surgery, stop Apatinib in the last cycle.
3 cycles of adjuvant chemotherapy including S-1 and Apatinib 4 to 6 weeks after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| conversion treatment | Experimental | Drug: S1/Paclitaxel chemotherapy plus Apatinibafter 3 cycles S1/Paclitaxel chemotherapy plus Apatinib,subsequent surgery will be conducted with curative intent |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- unresectable gastric cancer as proven histologically(AJCC, version 7) under any following condition: unable radical excision due to the local metastasis of invasion metastasis to the lymph node beside the abdominal aorta, non-extensive metastasis to liver( not more than three metastatic foci of radical excision), Peritoneal metastasis(CY1,P1,P2), kukerburg tumor
- Definitely diagnosed as above stage of gastric cancer before operation via CT of MRI, ultrasonic endoscopy, PET-CT, or through the laparoscopic exploration if necessary
- Untreated(e.g. radiotherapy, chemotherapy, target therapy and immunotherapy)
- Negative HER-2 state
- ECOG(Eastern Cooperative Oncology Group) :0~2
Key exclusion criteria (8 listed)
- not conforming above inclusion conditions
- Distal metastasis to lung, brain, and bone
- Ever operation on the stomach
- Operation intolerance due to other systemic basic disease
- Ever administrated with other drugs(including TCM drugs) before the recruitment, or no guarantee of progress according to the study requirement after recruitment
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 |
|---|---|---|
| S1/Paclitaxel chemotherapy plus ApatinibAlso: SPAS1:60mg twice daily(after the breakfast and supper) for two weeks, and then suspend for one week Paclitaxel:150mg/m2,iv, 3h, at day1 Apatinib:500mg once daily | Drug | conversion treatment |
Primary outcome
radical resection rate
Time frame: 4 months
the radical resection rates
3 secondary outcomes
overall survival
Time frame: 3 years
adverse events
Time frame: 6 months
reaction rate
Time frame: 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2016.
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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.
Xiangdong Cheng, MD principal investigator
The First Affiliated Hospital of Zhejiang Chinese Medical University
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 S1/Paclitaxel chemotherapy plus Apatinib in people with Gastric Cancer, run by The First Affiliated Hospital of Zhejiang Chinese Medical University 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 11 inclusion and 8 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 2016. 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?
Contact Xiangdong Cheng, MD (+86-057187070965, getfar@foxmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
radical resection rate (time frame: 4 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 2016.