Neoplasm, StomachPhase 1NCT03563326
Intraperitoneal Infusion of EpCAM CAR-T Cell in Advanced Gastric Cancer With Peritoneal Metastasis (WCH-GC-CART)
A Phase 1 study testing CAR-T cells targeting EpCAM and Chemotherapy in people with Neoplasm, Stomach and Metastases, Neoplasm, run by Jian-Kun Hu at 1 site in China.
Trial summary
To investigate the safety and efficacy of intraperitoneal infusion of EpCAM CAR-T cell in advanced gastric cancer with peritoneal metastasis by a prospective nonrandomized controlled trial. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Neoplasm, Stomach, Metastases, Neoplasm, Neoplasm Seeding
- What is being tested?
- CAR-T cells targeting EpCAM and Chemotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 30 Aug 2018to 31 Dec 2022
- Phase
- Phase 1
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with EpCAM positive gastric cancer who have peritoneal metastasis at first visit; Patients with highly suspected or previous proven peritoneal metastasis by biopsy, CT, digital rectal examination, etc. who failed to the routine therapies like chemotherapy;
- Age between 18 and 75;
- Estimated survival time is longer than 3 months;
- Eastern Cooperative Oncology Group (ECOG）scores 0-2;
- Hemoglobin≥90g/L, ANC≥1.5×109/L, PLT≥80×109/L;
- Negative pregnancy test for child-bearing period; both male and female patients should agree to apply effective contraceptive methods in the period of treatment and one year after treatment;
- Both patients and families totally understand the objectives and risks of the treatments and sign the informed consent.
Who cannot join
- Comorbidity with other diseases treated by immunosuppressive drugs or steroids therapy systematically;
- Uncontrolled active infection;
- HIV positive;
- Active hepatic B or C virus infection, active tuberculosis;
- Pregnant or lactation female;
- Disagree to apply effective contraceptive methods in the period of treatment and one year after treatment;
- Positive cytology examination alone.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041
Jian-Kun Hu
Jian-Kun Hu
About this study
Official title: Clinical Trial of Intraperitoneal CAR-T Cells Infusion for the Treatment of Advanced Gastric Cancer With Peritoneal Metastasis
To investigate the safety and efficacy of intraperitoneal infusion of EpCAM CAR-T cell in advanced gastric cancer with peritoneal metastasis by a prospective nonrandomized controlled trial.
Read the detailed description
Chimeric antigen receptor modified T (CAR-T) cells have the capability in targeting and recognizing tumor antigen, and can specifically recognize, bind and kill tumor cells with positive antigen. Through local drug delivery, CAR-T cells have successfully achieved remarkable effect to treat solid tumors. Gastric cancer is one of the most frequent malignant tumors with high mortality, especially in China. Peritoneal metastasis is one of the common routes of metastasis. Once peritoneal metastasis occurred, patients should be categorized as clinical pathological stage IV with extremely poor prognosis, and the effect of routine treatments would be unsatisfactory. Epithelial cell adhesion molecule (EpCAM) is highly expressed in gastric cancer cells and closely associated with the poor prognosis of patients. In our previous pre-clinical research researches, the investigators have obtained CAR-T cells targeting EpCAM (EpCAM CAR-T), and finished the preparations of cells which could be used in clinical practice. Based on our previous works, the investigators aim to investigate the safety and efficacy of peritoneal infusion of EpCAM CAR-T cell in advanced gastric cancer with peritoneal metastasis by a prospective nonrandomized controlled trial. The results of this clinical trial are expected to provide the new treatment strategy for gastric cancer patients with peritoneal metastasis.
- Conditions
- Neoplasm, Stomach, Metastases, Neoplasm, Neoplasm Seeding
- Being tested
- CAR-T cells targeting EpCAM, Chemotherapy
- Keywords
- Epithelial Cell Adhesion Molecule, Chimeric Antigen Receptor-modified T cell, Gastric carcinoma, Peritoneal metastasis
- Medical subject headings
- Stomach Neoplasms, Neoplasm Metastasis, Neoplasm Seeding, Colorectal Cancer, Hereditary Nonpolyposis, Type 8
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAR-T cells targeting EpCAMBiological
Biological: CAR-T cells targeting EpCAM
ChemotherapyBiological
Chemotherapy: determined by medical Oncologist
| Study group | Role | What they receive |
|---|---|---|
| CAR-T cell and chemotherapy | Experimental | Biological: CAR-T cells targeting EpCAM Chemotherapy: determined by medical Oncologist Receives: Biological: CAR-T cells targeting EpCAM; Biological: Chemotherapy |
| chemotherapy | Active comparator | Chemotherapy: determined by medical Oncologist Receives: Biological: Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
EpCAM CAR-T cells treatment related adverse events
Adverse events after receiving EpCAM CAR-T cells treatment, according to NCI-CTCAE v4.0.
Measured: 4 weeks
Secondary outcomes (3)
Overall survival outcome
2-year overall survival rate
Measured: 2 years
Metabolism kinetics of CAR-T cells
The level of CAR-T cells will be tested regularly by Real-time Quantitative Polymerase Chain Reaction Detecting System(qPCR) or Flow cytometry.
Measured: 2 years
Progress free survival outcome
2-year progress free survival
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2018
- Study start30 Aug 2018
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2022 (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 Neoplasm, StomachStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jian-Kun Hu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jian-Kun Hu, West China Hospital
- Investigators
- Jian-Kun Hu, M.D. Ph.D., Principal investigator, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03563326
- Sponsor's protocol ID
- WCH-GC-CART
- Status last verified
- Sep 2018
- First submitted
- 5 May 2018
- Last updated
- 17 Sep 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: pending
Publications
Sarkar T, Sarkar T, Goswami M, Robaszkiewicz A, Sarkar K. Integrated transcriptome analysis and in silico investigations identify KHDRBS3 to target with steroidal lactone in paclitaxel resistance breast cancer. Biochem Biophys Res Commun. 2025 Sep 1;777:152332. doi: 10.1016/j.bbrc.2025.152332. Epub 2025 Jul 10.
PubMed 40651363
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial of Intraperitoneal CAR-T Cells Infusion for the Treatment of Advanced Gastric Cancer With Peritoneal Metastasis
- ClinicalTrials.gov ID
- NCT03563326
- Acronym / sponsor ID
- WCH-GC-CART
- Conditions
- Neoplasm, Stomach, Metastases, Neoplasm, Neoplasm Seeding
- Keywords
- Epithelial Cell Adhesion Molecule, Chimeric Antigen Receptor-modified T cell, Gastric carcinoma, Peritoneal metastasis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Jian-Kun HuUniversity, hospital or other
- Study start
- 30 Aug 2018 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 20 Jun 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.
To investigate the safety and efficacy of intraperitoneal infusion of EpCAM CAR-T cell in advanced gastric cancer with peritoneal metastasis by a prospective nonrandomized controlled trial.
Detailed description
Chimeric antigen receptor modified T (CAR-T) cells have the capability in targeting and recognizing tumor antigen, and can specifically recognize, bind and kill tumor cells with positive antigen. Through local drug delivery, CAR-T cells have successfully achieved remarkable effect to treat solid tumors. Gastric cancer is one of the most frequent malignant tumors with high mortality, especially in China. Peritoneal metastasis is one of the common routes of metastasis. Once peritoneal metastasis occurred, patients should be categorized as clinical pathological stage IV with extremely poor prognosis, and the effect of routine treatments would be unsatisfactory. Epithelial cell adhesion molecule (EpCAM) is highly expressed in gastric cancer cells and closely associated with the poor prognosis of patients. In our previous pre-clinical research researches, the investigators have obtained CAR-T cells targeting EpCAM (EpCAM CAR-T), and finished the preparations of cells which could be used in clinical practice. Based on our previous works, the investigators aim to investigate the safety and efficacy of peritoneal infusion of EpCAM CAR-T cell in advanced gastric cancer with peritoneal metastasis by a prospective nonrandomized controlled trial. The results of this clinical trial are expected to provide the new treatment strategy for gastric cancer patients with peritoneal metastasis.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CAR-T cell and chemotherapy | Experimental | Biological: CAR-T cells targeting EpCAM, Biological: ChemotherapyBiological: CAR-T cells targeting EpCAM Chemotherapy: determined by medical Oncologist |
| chemotherapy | Active comparator | Biological: ChemotherapyChemotherapy: determined by medical Oncologist |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with EpCAM positive gastric cancer who have peritoneal metastasis at first visit; Patients with highly suspected or previous proven peritoneal metastasis by biopsy, CT, digital rectal examination, etc. who failed to the routine therapies like chemotherapy;
- Age between 18 and 75;
- Estimated survival time is longer than 3 months;
- Eastern Cooperative Oncology Group (ECOG）scores 0-2;
- Hemoglobin≥90g/L, ANC≥1.5×109/L, PLT≥80×109/L;
Key exclusion criteria (7 listed)
- Comorbidity with other diseases treated by immunosuppressive drugs or steroids therapy systematically;
- Uncontrolled active infection;
- HIV positive;
- Active hepatic B or C virus infection, active tuberculosis;
- Pregnant or lactation female;
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 |
|---|---|---|
| CAR-T cells targeting EpCAMBiological: CAR-T cells targeting EpCAM | Biological | CAR-T cell and chemotherapy |
| ChemotherapyChemotherapy: determined by medical Oncologist | Biological | CAR-T cell and chemotherapy, chemotherapy |
Primary outcome
EpCAM CAR-T cells treatment related adverse events
Time frame: 4 weeks
Adverse events after receiving EpCAM CAR-T cells treatment, according to NCI-CTCAE v4.0.
3 secondary outcomes
Overall survival outcome
Time frame: 2 years
Metabolism kinetics of CAR-T cells
Time frame: 2 years
Progress free survival outcome
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2018.
- Derived from this study: PubMed 40651363Sarkar T, Sarkar T, Goswami M, Robaszkiewicz A, Sarkar K. Integrated transcriptome analysis and in silico investigations identify KHDRBS3 to target with steroidal lactone in paclitaxel resistance breast cancer. Biochem Biophys Res Commun. 2025 Sep 1;777:152332. doi: 10.1016/j.bbrc.2025.152332. Epub 2025 Jul 10.
- Individual participant dataSharing planned: Undecided. pending
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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.
Jian-Kun Hu, M.D. Ph.D. principal investigator
West China Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CAR-T cells targeting EpCAM and Chemotherapy in people with Neoplasm, Stomach and Metastases, Neoplasm, run by Jian-Kun Hu 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 7 inclusion and 7 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 17 Sep 2018. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Jian-Kun Hu, M.D. Ph.D. (02885422878, hujkwch@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EpCAM CAR-T cells treatment related adverse events (time frame: 4 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 NCT03563326, 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 17 Sep 2018.