Gastric Cancer With Positive Exfoliative Cancer CellsPhase 2NCT03718624
A Study of Intraperitoneal and Intravenous Paclitaxel Plus Apatinib and S-1 Conversion Therapy for Gastric Cancer With Positive Exfoliative Cancer Cells
A Phase 2 study testing apatinib, paclitaxel and S-1 in people with Gastric Cancer With Positive Exfoliative Cancer Cells, run by Hebei Medical University.
Trial summary
The purpose of this study is to investigate the efficacy and safety of intraperitoneal and intravenous paclitaxel plus apatinib and S-1 in the conversion therapy of gastric cancer with positive exfoliative cancer cells Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Gastric Cancer With Positive Exfoliative Cancer Cells
- What is being tested?
- apatinib, paclitaxel and S-1
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- 30 Oct 2018to 30 Oct 2020
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Untreated (e.g. chemotherapy, radiotherapy and other antitumor therapy);
- Age:18 to 70 years old;
- Man or female (except pregnant and lactating women);
- Confirmed to gastric adenocarcinoma;
- Proven gastric cancer of T stage was T3 and T4, and no distant metastasis was observed. The exfoliative cancer cells detection in peritoneal washes was positive;
- Blood cell count has to meet the following criteria:
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- WBC≥3.5×109/L; ANC≥1.5×109/L; PLT≥100×109/L; HB≥90g/L;
- Liver/kidney function has to meet the following criteria:
- ALT and AST≤2.5ULN TBIL<1.5ULN； Serum creatinine ≤1.5ULN;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
- Participants were willing to join in this study, good adherence and written informed consent.
Who cannot join
- Patients with other malignant tumors within 5 years;
- Metastasis was found to be visible to the naked eye;
- It has serious or uncontrolled heart diseases and infections (Including atrial fibrillation, angina pectoris, cardiac insufficiency, ejection fraction less than 50%, poor-controlled hypertension and so on);
- History of psychiatric drugs abuse and can't quit or patients with mental disorders;
- Patients with severe or uncontrollable mental illness;
- Patients with tendency of gastrointestinal bleeding, including the following: a local active ulcerative lesions, and defecate occult blood (+ +).Has melena and hematemesis in two months;
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- Pregnant or lactating women;
- It have serious harm to the patient's safety or affect the patients who have completed the research.
- The researchers think inappropriate.
Trial locations and contacts
No sites are listed yet.
About this study
The purpose of this study is to investigate the efficacy and safety of intraperitoneal and intravenous paclitaxel plus apatinib and S-1 in the conversion therapy of gastric cancer with positive exfoliative cancer cells
- Being tested
- apatinib, paclitaxel, S-1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
apatinibDrug
apatinib：500mg qd po, 28 days is a cycle. preoperative 2 cycles, 2 cycles after surgery.
paclitaxelDrug
Paclitaxel: intraperitoneal paclitaxel 20 mg/m2 and intravenous paclitaxel 50 mg/m2 on days 1 and 8 ，21 days is a cycle. preoperative 3 cycles, 3 cycles after surgery.
S-1Drug
S-1： According to the body surface area, BSA <1.25m2，40mg bid; 1.25m2≤BSA≤1.5m2，50mg bid; BSA >1.5m2, 60mg bid. Take the medicine twice daily for 2 weeks, then suspend for 1 week. preoperative 3 cycles, 3 cycles after surgery.
| Study group | Role | What they receive |
|---|---|---|
| paclitaxel,apatinib and S-1 | Experimental | Not described Receives: Drug: apatinib; Drug: paclitaxel; Drug: S-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
R0-resection rate
There was no residual by the microscope
Measured: within 3 weeks after surgery
Conversion to negative rate
Exfoliative cytology positive gastric cancer conversion to negative rate.
Measured: within 3 weeks after surgery
Secondary outcomes (3)
Overall survival (OS)
Baseline to measured date of death from any cause
Measured: 5years
Progression free survival (PFS)
Baseline to measured date of progression or death from any cause
Measured: 5years
Adverse events
Toxicity according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.The number of Participants with adverse events will be recorded at each treatment visit.
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 posted24 Oct 2018
- Study start30 Oct 2018 (estimated)
- Primary completion30 Oct 2019 (estimated)
- Study completion30 Oct 2020 (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 Gastric Cancer With Positive Exfoliative Cancer CellsStudies 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
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hebei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qun Zhao, Hebei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03718624
- Sponsor's protocol ID
- HRA-G03
- Status last verified
- Oct 2018
- First submitted
- 23 Oct 2018
- Last updated
- 31 Oct 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ding P, Guo H, Ma W, Wu J, Wu H, Li T, Gu R, Zhang L, Meng N, Li X, Guo Z, Meng L, Zhao Q. Transcriptomics-driven non-invasive liquid biopsy for diagnosing peritoneal lavage cytology-positive gastric cancer. NPJ Precis Oncol. 2026 Jul 15. doi: 10.1038/s41698-026-01531-w. Online ahead of print.
PubMed 42457866
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Intraperitoneal and Intravenous Paclitaxel Plus Apatinib and S-1 Conversion Therapy for Gastric Cancer With Positive Exfoliative Cancer Cells
- ClinicalTrials.gov ID
- NCT03718624
- Acronym / sponsor ID
- HRA-G03
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Hebei Medical UniversityUniversity, hospital or other
- Study start
- 30 Oct 2018 (estimated)
- Primary completion
- 30 Oct 2019 (estimated)
- Study completion
- 30 Oct 2020 (estimated)
- First posted
- 24 Oct 2018 (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.
The purpose of this study is to investigate the efficacy and safety of intraperitoneal and intravenous paclitaxel plus apatinib and S-1 in the conversion therapy of gastric cancer with positive exfoliative cancer cells
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| paclitaxel,apatinib and S-1 | Experimental | Drug: apatinib, Drug: paclitaxel, Drug: S-1 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Untreated (e.g. chemotherapy, radiotherapy and other antitumor therapy);
- Age:18 to 70 years old;
- Man or female (except pregnant and lactating women);
- Confirmed to gastric adenocarcinoma;
- Proven gastric cancer of T stage was T3 and T4, and no distant metastasis was observed. The exfoliative cancer cells detection in peritoneal washes was positive;
Key exclusion criteria (9 listed)
- Patients with other malignant tumors within 5 years;
- Metastasis was found to be visible to the naked eye;
- It has serious or uncontrolled heart diseases and infections (Including atrial fibrillation, angina pectoris, cardiac insufficiency, ejection fraction less than 50%, poor-controlled hypertension and so on);
- History of psychiatric drugs abuse and can't quit or patients with mental disorders;
- Patients with severe or uncontrollable mental illness;
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：500mg qd po, 28 days is a cycle. preoperative 2 cycles, 2 cycles after surgery. | Drug | paclitaxel,apatinib and S-1 |
| paclitaxelPaclitaxel: intraperitoneal paclitaxel 20 mg/m2 and intravenous paclitaxel 50 mg/m2 on days 1 and 8 ，21 days is a cycle. preoperative 3 cycles, 3 cycles after surgery. | Drug | paclitaxel,apatinib and S-1 |
| S-1S-1： According to the body surface area, BSA <1.25m2，40mg bid; 1.25m2≤BSA≤1.5m2，50mg bid; BSA >1.5m2, 60mg bid. Take the medicine twice daily for 2 weeks, then suspend for 1 week. preoperative 3 cycles, 3 cycles after surgery. | Drug | paclitaxel,apatinib and S-1 |
Primary outcome
R0-resection rate
Time frame: within 3 weeks after surgery
There was no residual by the microscope
Conversion to negative rate
Time frame: within 3 weeks after surgery
Exfoliative cytology positive gastric cancer conversion to negative rate.
3 secondary outcomes
Overall survival (OS)
Time frame: 5years
Progression free survival (PFS)
Time frame: 5years
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 31 Oct 2018.
- Derived from this study: PubMed 42457866Ding P, Guo H, Ma W, Wu J, Wu H, Li T, Gu R, Zhang L, Meng N, Li X, Guo Z, Meng L, Zhao Q. Transcriptomics-driven non-invasive liquid biopsy for diagnosing peritoneal lavage cytology-positive gastric cancer. NPJ Precis Oncol. 2026 Jul 15. doi: 10.1038/s41698-026-01531-w. Online ahead of print.
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, paclitaxel and S-1 in people with Gastric Cancer With Positive Exfoliative Cancer Cells, run by Hebei Medical University.
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 9 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 31 Oct 2018. 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 Qun Zhao (13930162111, Zhaoqun516@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
R0-resection rate (time frame: within 3 weeks after surgery). 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?
On the ClinicalTrials.gov record for NCT03718624, 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 31 Oct 2018.