Gastric AdenocarcinomaNCT04047953
Paclitaxel (Albumin-bound) Combined With Oxaliplatin and S-1 Conversion Therapy for Gastric Adenocarcinoma
A study testing Paclitaxel (albumin-bound) combined with Oxaliplatin and S-1 in people with Gastric Adenocarcinoma, run by Peking University Cancer Hospital & Institute at 1 site in China.
Trial summary
To evaluate the efficacy and safety of Paclitaxel (albumin-bound) combined with Oxaliplatin and S-1 conversion therapy for initial unresectable local progression or potential resectable metastatic gastric adenocarcinoma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Adenocarcinoma
- What is being tested?
- Paclitaxel (albumin-bound) combined with Oxaliplatin and S-1
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteChina
- Study dates
- 10 Sep 2019to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 of 18-75 years; male or female.
- Karnofsky Performance Status Score ≥70.
- Histological diagnosis of gastric adenocarcinoma, HER2 expression negative.
- The initial unresectable locally advanced or potentially resectable metastatic gastric adenocarcinoma, potentially resectable factor includes a single liver metastases, localized abdominal para-aortic lymph node (16a1 / b2) metastasis or positive abdominal free cancer cells.
- Physical condition and organ function allow for larger abdominal surgery.
- Subject baseline blood routine and blood biochemistry indexes meet the following criteria: hemoglobin(HB) ≥90 g/L; absolute neutrophil count(ANC) ≥1.5×109 /L; platelet count(PLT) ≥100×109 /L; alanine glutamate transaminase (ALT) and glutamate transaminase (AST) ≤2.5 x upper limit of normal range (ULN); total bilirubin (TBIL)≤1.5 x upper limit of normal range (ULN); Creatinine(Cr)≤1.5 x upper limit of normal range(ULN); Serum albumin≥30g/L.
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- Echocardiographic scan confirmed left ventricular ejection fraction (LVEF) ≥ 50%.
- No serious accompanying disease lead to a survival period of <5 years.
- Agree and be able to follow the protocol during the study period.
- Written informed consent was provided prior to the study screening and the patient was informed that the study could be withdrawn at any time during the study without any loss.
Who cannot join
- For the treatment of the gastric cancer, patients who have received cytotoxic chemotherapy, radiotherapy or immunotherapy, except corticosteroids.
- Pregnancy or breastfeeding woman.
- Women of childbearing age who had a positive pregnancy test at baseline or who did not undergo a pregnancy test. Menopausal women must be stopped for at least 12 months to ensure that no pregnancy is possible.
- Men and women who have sex (with fertility probability) are reluctant to contraception during the study.
- Patients with ascites and positive abdominal free cancer cells.
- There are other history of malignant disease in the last 5 years, except for cured skin cancer and cervical carcinoma in situ.
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- Those with a history of epilepsy, central nervous system disease, or mental disorder may be judged by the investigator that their clinical severity may hinder the signing of informed consent or affect the patient's oral medication compliance.
- Clinically severe (active) heart disease, such as symptomatic coronary heart disease, New York Heart Association (NYHA) class II or more severe congestive heart failure or severe drug-affected arrhythmias, or there is a history of myocardial infarction in the last 12 months.
- Upper gastrointestinal stagnation or abnormal physiological function or malabsorption syndrome may affect the absorption of S-1.
- It is known to have peripheral neuropathy ≥ NCI CTC AE grade 2. However, only the deep sputum reflex (DTR) disappears and the patient does not have to be excluded.
- Organ transplantation requires immunosuppressive therapy.
- Severe uncontrolled recurrent infections, or other serious uncontrolled concomitant diseases.
- Moderate or severe renal impairment [creatinine clearance equal to or lower than 50ml/min (calculated according to Cockcroft and Gault equations), or serum creatinine > upper normal limit (ULN).
- Those suffering from dihydropyrimidine dehydrogenase (DPD) deficiency are known.
- Those who are allergic to taxanes or any research ingredients.
- Those who received research medications or preparations/treatments (ie, participated in other trials) within 4 weeks prior to enrollment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality
Jiafu Ji, MD, 86-010-88196048, jiafuj@hotmail.com
Zhaode Bu, MD, 86-010-88196945, buzhaode@cjcrcn.org
About this study
Official title: The Study of Paclitaxel (Albumin-bound) Combined With Oxaliplatin and S-1 Conversion Therapy for Initial Unresectable Local Advanced or Potentially Resectable Metastatic Gastric Adenocarcinoma
To evaluate the efficacy and safety of Paclitaxel (albumin-bound) combined with Oxaliplatin and S-1 conversion therapy for initial unresectable local progression or potential resectable metastatic gastric adenocarcinoma.
- Conditions
- Gastric Adenocarcinoma
- Being tested
- Paclitaxel (albumin-bound) combined with Oxaliplatin and S-1
- Keywords
- Paclitaxel (albumin-bound), gastric cancer, conversion therapy
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paclitaxel (albumin-bound) combined with Oxaliplatin and S-1Drug
Also called Paclitaxel (albumin-bound) + Oxaliplatin + S-1, Nab-paclitaxel + Oxaliplatin + S-1
Paclitaxel (albumin-bound) : 150 mg/m2, iv,d1. S-1 : 40~60mg，bid, d1-14( BSA<1.25m2，40mg；1.25m2≤BSA≤1.5m2，50mg；BSA>1.5m2，60mg) Oxaliplatin: 85mg/m2, iv, d1. Twenty-one days per cycle, a total of four cycles, after two cycles of treatment, the tumor was evaluated. The clinical efficacy was evaluated as CR\PR\SD and decided by the investigator to continue the treatment for two cycles or directly.
| Study group | Role | What they receive |
|---|---|---|
| Conversion Therapy | Experimental | Paclitaxel (albumin-bound) +S-1+Oxaliplatin Receives: Drug: Paclitaxel (albumin-bound) combined with Oxaliplatin and S-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
R0 resection rate
Proportion of patients who achieved R0 resection
Measured: within 4 weeks following the operation
Secondary outcomes (3)
Progression free survival (PFS)
the time from registration to the date of disease progression or death resulting from any cause.
Measured: 5 years
overall survival (OS)
the time from registration to the date of death resulting from any cause or the last follow-up visit.
Measured: 5 years
Adverse Events(AEs)
AEs are evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events v5.0.
Measured: until 28 days after the last study drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2019
- Study start10 Sep 2019
- Primary completion31 Dec 2023 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Peking University Cancer Hospital & InstituteThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 95 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhaode Bu, Peking University Cancer Hospital & Institute
- Investigators
- Jiafu ji, MD, Principal investigator, Peking University Cancer Hospital & InstituteZhaode Bu, MD, Principal investigator, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04047953
- Sponsor's protocol ID
- GC-conversion
- Status last verified
- Apr 2023
- First submitted
- 6 Aug 2019
- Last updated
- 5 Apr 2023
- 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 5 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Study of Paclitaxel (Albumin-bound) Combined With Oxaliplatin and S-1 Conversion Therapy for Initial Unresectable Local Advanced or Potentially Resectable Metastatic Gastric Adenocarcinoma
- ClinicalTrials.gov ID
- NCT04047953
- Acronym / sponsor ID
- GC-conversion
- Conditions
- Gastric Adenocarcinoma
- Keywords
- Paclitaxel (albumin-bound), gastric cancer, conversion therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 95 participants (estimated)
- Lead sponsor
- Peking University Cancer Hospital & InstituteUniversity, hospital or other
- Study start
- 10 Sep 2019 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 7 Aug 2019 (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.
To evaluate the efficacy and safety of Paclitaxel (albumin-bound) combined with Oxaliplatin and S-1 conversion therapy for initial unresectable local progression or potential resectable metastatic gastric adenocarcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Conversion Therapy | Experimental | Drug: Paclitaxel (albumin-bound) combined with Oxaliplatin and S-1Paclitaxel (albumin-bound) +S-1+Oxaliplatin |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age of 18-75 years; male or female.
- Karnofsky Performance Status Score ≥70.
- Histological diagnosis of gastric adenocarcinoma, HER2 expression negative.
- The initial unresectable locally advanced or potentially resectable metastatic gastric adenocarcinoma, potentially resectable factor includes a single liver metastases, localized abdominal para-aortic lymph node (16a1 / b2) metastasis or positive abdominal free cancer cells.
- Physical condition and organ function allow for larger abdominal surgery.
Key exclusion criteria (16 listed)
- For the treatment of the gastric cancer, patients who have received cytotoxic chemotherapy, radiotherapy or immunotherapy, except corticosteroids.
- Pregnancy or breastfeeding woman.
- Women of childbearing age who had a positive pregnancy test at baseline or who did not undergo a pregnancy test. Menopausal women must be stopped for at least 12 months to ensure that no pregnancy is possible.
- Men and women who have sex (with fertility probability) are reluctant to contraception during the study.
- Patients with ascites and positive abdominal free cancer cells.
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 |
|---|---|---|
| Paclitaxel (albumin-bound) combined with Oxaliplatin and S-1Also: Paclitaxel (albumin-bound) + Oxaliplatin + S-1, Nab-paclitaxel + Oxaliplatin + S-1Paclitaxel (albumin-bound) : 150 mg/m2, iv,d1. S-1 : 40~60mg，bid, d1-14( BSA<1.25m2，40mg；1.25m2≤BSA≤1.5m2，50mg；BSA>1.5m2，60mg) Oxaliplatin: 85mg/m2, iv, d1. Twenty-one days per cycle, a total of four cycles, after two cycles of treatment, the tumor was evaluated. The clinical efficacy was evaluated as CR\PR\SD and decided by the investigator to continue the treatment for two cycles or directly. | Drug | Conversion Therapy |
Primary outcome
R0 resection rate
Time frame: within 4 weeks following the operation
Proportion of patients who achieved R0 resection
3 secondary outcomes
Progression free survival (PFS)
Time frame: 5 years
overall survival (OS)
Time frame: 5 years
Adverse Events(AEs)
Time frame: until 28 days after the last study drug administration
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2023.
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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.
Jiafu ji, MD principal investigator
Peking University Cancer Hospital & Institute
Zhaode Bu, MD principal investigator
Peking University Cancer Hospital & Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Paclitaxel (albumin-bound) combined with Oxaliplatin and S-1 in people with Gastric Adenocarcinoma, run by Peking University Cancer Hospital & Institute 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 10 inclusion and 16 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: looking for participants now, as of the sponsor's last update on 5 Apr 2023. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jiafu ji, MD (86-010-88196048, jiafuj@hotmail.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 4 weeks following the operation). 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 5 Apr 2023.