Gastric CancerPhase 2NCT02504229
DC-CIK In Combination With Chemotherapy ( Gio / Oxaliplatin or Cisplatin ) Versus First-line Chemotherapy for Locally Advanced Unresectable or Metastatic Gastric Adenocarcinoma Randomized Controlled Phase II Clinical Study of Treatment
A Phase 2 study testing autologous dendritic cells co-cultured with cytokine-induced killer cells, Gimeracil and Oteracil Porassium Capsules and Oxaliplatin in people with Gastric Cancer, run by Beijing Biohealthcare Biotechnology Co.,Ltd at 1 site in China.
Trial summary
This study evaluates the therapeutic effects of autologous dendritic cells co-cultured with cytokine-induced killer cells (DC-CIK) combined with S-1 ((Tegafur, Gimeracil, and Oteracil Potassium) and oxaliplatin adjuvant chemotherapy in locally advanced unresectable or metastaticgastric cancer. 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?
- autologous dendritic cells co-cultured with cytokine-induced killer cells, Gimeracil and Oteracil Porassium Capsules and Oxaliplatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- Nov 2014to Jul 2018
- 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
- Age>18y;
- ECOG physical status 0-1;
- The histologic diagnosis of stomach/gastroesophageal junction adenocarcinoma;
- According to the RECIST 1.1 standard with measurable or evaluable lesion;
- Accept swallow oral drug;
- WBC≧4.0×10^9/L;ALC≧0.8×10^9/L;ANC≧1.5×10^9/L;PLT≧100×10^9/L;ALT,AST≦2.5 times of the normal limit;ALP≦2.5 times of the normal limit;TBIL﹤1.5 times of the normal limit;SCr﹤1 times of the normal limit;ALB≧30g/L;
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- The expected survival time of more than 3 months;
- good compliance;
- Provide written informed consent.
Who cannot join
- Vital organs (heart,liver,kidney) function is serious dysfunction;
- Patients received organ transplantation;
- Patients with other malignant tumors or have occurred brain metastasis;
- Patients with history of autoimmune disease;
- Patients in pregnancy or breast-feeding period(women of child-bearing age need to check pregnancy test);
- Patients with acute infection disease or in chronic active stage;
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- Patients with clear history of drug allergy or belong to allergic constitution;
- Patients received chemotherapy,radiation therapy, immunosuppressive drugs (cyclosporine A,etc.) or other immune treatment in 4 weeks;
- Patients received other clinical trials in 4 weeks.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Chinese Academy of Medical Sciences Tumor Hospital
Beijing, Beijing Municipality
jinwan Wang, lyang69@sina.com
lin Yang, lyang69@sina.com
About this study
This study evaluates the therapeutic effects of autologous dendritic cells co-cultured with cytokine-induced killer cells (DC-CIK) combined with S-1 ((Tegafur, Gimeracil, and Oteracil Potassium) and oxaliplatin adjuvant chemotherapy in locally advanced unresectable or metastaticgastric cancer. Half of participants will receive DC-CIK combined with S-1 and oxaliplatin adjuvant chemotherapy,while the other half will receive S-1 and oxaliplatin adjuvant chemotherapy served as controls.
- Conditions
- Gastric Cancer
- Being tested
- autologous dendritic cells co-cultured with cytokine-induced killer cells, Gimeracil and Oteracil Porassium Capsules, Oxaliplatin
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
autologous dendritic cells co-cultured with cytokine-induced killer cellsBiological
Gimeracil and Oteracil Porassium CapsulesDrug
OxaliplatinDrug
Also called Eloxatin
| Study group | Role | What they receive |
|---|---|---|
| Chemotherapy+DC-CIK | Experimental | Combined treatment group:mononuclear cells were obtained aseptically with blood cell separator composition spheresis 1 day before SOX program chemotherapy, cultured DC-CIK cells. SOX program was acted on Day 2. Cells were cultured 14d,2 times back to the patient.A 21d was a cycle, then evaluated the therapeutic effect after two cycles. Receives: Biological: autologous dendritic cells co-cultured with cytokine-induced killer cells; Drug: Gimeracil and Oteracil Porassium Capsules; Drug: Oxaliplatin |
| Chemotherapy alone | Active comparator | Chemotherapy: two groups were treated with SOX program,specific drugs:Venoclysis of oxaliplatin 130mg/㎡;Day 1; Tegafur,Gimeracil and Oteracil Porassium Capsules 80mg/㎡/d,two oral/d;Day 1 to 12; 21d as one cycle of treatment, evaluated the therapeutic effect after two cycles. Receives: Drug: Gimeracil and Oteracil Porassium Capsules; Drug: Oxaliplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2015 (estimated)
- Study startNov 2014
- Primary completionJul 2018 (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 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Biohealthcare Biotechnology Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- jinwan Wang, Principal investigator, Chinese Academy of Medical Sciences Tumor Hospitallin yang, Principal investigator, Chinese Academy of Medical Sciences Tumor Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02504229
- Sponsor's protocol ID
- GC-A-004
- Status last verified
- Jul 2015
- First submitted
- 20 Jul 2015
- Last updated
- 21 Jul 2015
- Results posted
- No
Publications
Ma X, Peng L, Wang J, Gao L, Zhang W, Lu X, Liu J, Yang L. Autologous CIK cells combined with chemotherapy as the first-line treatment for locally advanced or metastatic gastric cancer is safe and feasible. Front Immunol. 2023 Nov 1;14:1267369. doi: 10.3389/fimmu.2023.1267369. eCollection 2023.
PubMed 38022664
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DC-CIK In Combination With Chemotherapy ( Gio / Oxaliplatin or Cisplatin ) Versus First-line Chemotherapy for Locally Advanced Unresectable or Metastatic Gastric Adenocarcinoma Randomized Controlled Phase II Clinical Study of Treatment
- ClinicalTrials.gov ID
- NCT02504229
- Acronym / sponsor ID
- GC-A-004
- Conditions
- Gastric Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Beijing Biohealthcare Biotechnology Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- Nov 2014
- Primary completion
- Jul 2018 (estimated)
- First posted
- 21 Jul 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.
This study evaluates the therapeutic effects of autologous dendritic cells co-cultured with cytokine-induced killer cells (DC-CIK) combined with S-1 ((Tegafur, Gimeracil, and Oteracil Potassium) and oxaliplatin adjuvant chemotherapy in locally advanced unresectable or metastaticgastric cancer. Half of participants will receive DC-CIK combined with S-1 and oxaliplatin adjuvant chemotherapy,while the other half will receive S-1 and oxaliplatin adjuvant chemotherapy served as controls.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chemotherapy+DC-CIK | Experimental | Biological: autologous dendritic cells co-cultured with cytokine-induced killer cells, Drug: Gimeracil and Oteracil Porassium Capsules, Drug: OxaliplatinCombined treatment group:mononuclear cells were obtained aseptically with blood cell separator composition spheresis 1 day before SOX program chemotherapy, cultured DC-CIK cells. SOX program was acted on Day 2. Cells were cultured 14d,2 times back to the patient.A 21d was a cycle, then evaluated the therapeutic effect after two cycles. |
| Chemotherapy alone | Active comparator | Drug: Gimeracil and Oteracil Porassium Capsules, Drug: OxaliplatinChemotherapy: two groups were treated with SOX program,specific drugs:Venoclysis of oxaliplatin 130mg/㎡;Day 1; Tegafur,Gimeracil and Oteracil Porassium Capsules 80mg/㎡/d,two oral/d;Day 1 to 12; 21d as one cycle of treatment, evaluated the therapeutic effect after two cycles. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age>18y;
- ECOG physical status 0-1;
- The histologic diagnosis of stomach/gastroesophageal junction adenocarcinoma;
- According to the RECIST 1.1 standard with measurable or evaluable lesion;
- Accept swallow oral drug;
Key exclusion criteria (9 listed)
- Vital organs (heart,liver,kidney) function is serious dysfunction;
- Patients received organ transplantation;
- Patients with other malignant tumors or have occurred brain metastasis;
- Patients with history of autoimmune disease;
- Patients in pregnancy or breast-feeding period(women of child-bearing age need to check pregnancy test);
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 |
|---|---|---|
| autologous dendritic cells co-cultured with cytokine-induced killer cells | Biological | Chemotherapy+DC-CIK |
| Gimeracil and Oteracil Porassium Capsules | Drug | Chemotherapy alone, Chemotherapy+DC-CIK |
| OxaliplatinAlso: Eloxatin | Drug | Chemotherapy alone, Chemotherapy+DC-CIK |
Primary outcome
Progression free survival
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2015.
- Derived from this study: PubMed 38022664Ma X, Peng L, Wang J, Gao L, Zhang W, Lu X, Liu J, Yang L. Autologous CIK cells combined with chemotherapy as the first-line treatment for locally advanced or metastatic gastric cancer is safe and feasible. Front Immunol. 2023 Nov 1;14:1267369. doi: 10.3389/fimmu.2023.1267369. eCollection 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. This study is not recruiting at the moment.
jinwan Wang principal investigator
Chinese Academy of Medical Sciences Tumor Hospital
lin yang principal investigator
Chinese Academy of Medical Sciences Tumor Hospital
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 autologous dendritic cells co-cultured with cytokine-induced killer cells, Gimeracil and Oteracil Porassium Capsules and Oxaliplatin in people with Gastric Cancer, run by Beijing Biohealthcare Biotechnology Co.,Ltd 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 9 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 21 Jul 2015. 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 Jingwei liu, PhD (13241238766, ljwgirl361@163.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: 6 weeks). 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 NCT02504229, 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 21 Jul 2015.