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Combination of anti-PD-1 and introperitoneal cell therapy in gastric cancer patients with ascites/ peritoneal metastasis

Combination of anti-PD-1 and introperitoneal cell therapy in gastric cancer patients with ascites/ peritoneal metastasis

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900024440
Enrollment
Unknown
Registered
2019-07-12
Start date
2019-08-22
Completion date
Unknown
Last updated
2019-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

gastric cancer

Interventions

single group:anti-PD1 antibody,Smart-T

Sponsors

The Affiliated Hospital of Nanjing University Medical School
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged >= 18 years. 2. Histologically or cytologically confirmed gastric cancer with malignant peritoneal effusion or peritoneal metastasis. 3. Patients with gastric cancer who failed previous standard treatment, or who refused follow-up chemotherapy, expected to survive for more than 8 weeks. 4. The patient has not previously received immunotherapy. 5. Appropriate protective measures (contraception or other methods of birth control) should be taken before and during the trial. 6. Informed consent has been signed. 7. Ability to follow study protocol and follow up procedures.

Exclusion criteria

Exclusion criteria: 1. Previously received tumor chemotherapy, radiotherapy and other anti-tumor treatment within one month; Received any form of immunotherapy within the previous 3 months. 2. Patients had a history of other tumors, except for cervical carcinoma in situ, treated squamous cell carcinoma or bladder epithelial neoplasm (Ta and TIS), or other malignancies that had undergone radical treatment (at least 5 years prior to enrollment). 3. Leukocyte count 3 x Upper normal value,Total bilirubin. 5. Creatinine clearance = level 2 of NCI-CTC, Third edition). 8. Patients have HIV infection, HCV infection, uncontrolled coronary artery disease or asthma, uncontrollable cerebrovascular disease or other diseases that the investigator believes are unincorporated. 9. Pregnant, lactating women. Women of childbearing age must be tested negative for pregnancy test within 7 days prior to enrollment. 10. Drug abuse, clinical or psychological or social factors affect informed consent or research implementation. 11. Those who may be allergic to research drugs. 12. Patients who are unable to perform lymphocyte separation or peripheral venous access cannot be opened. 13. Any uncertainty that affects patient safety or compliance. 14. Feasibility assessment during the screening process showed that T lymphocytes were not sufficient for CD3 and IL-2 stimulation signals to trigger a cell proliferation response.

Design outcomes

Primary

MeasureTime frame
OS;

Secondary

MeasureTime frame
Imaging evaluation;Ascites volume;improvement of quality of life;safety evaluation;

Countries

China

Contacts

Public ContactJia Wei

The Affiliated Hospital of Nanjing University Medical School

weijia01627@hotmail.com+86 13951785234

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026