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Gastric cancer immunotherapy

Phase 1
Conditions
gastric cancer.
Malignant neoplasm of stomach
Registration Number
IRCT20170208032451N1
Lead Sponsor
Mashhad University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
All
Target Recruitment
5
Inclusion Criteria

Patients with gastric adenocarcinoma whose histologically advanced malignancy (spread of cancer cells to lymph nodes and tumor metastasis) has been confirmed and they have filled out the informed consent form
The patient must be over 18 years old at the time of diagnosis.
Natural laboratory parameters, including these tests: Protein C& S, D-Dimer, VWF, CPK,LDH, TI, ALP, Lipase, Amylase, GGT, OB,CBC diff, Hgb electrophoresis, Serum Iron, Transferrin saturation, TIBC, CH50 (total complement), ESR, CRP, ACE, ANA, Anti CCP, RF, Auto antibodies, UA, Uric acid, Cr, Urea, SGPT, SGOT, Bilirubin, Albumin, Lipid profile, ACTH, Cortisol, FBS, HbA1c, OGT , ACTH, Cortisol, FBS, HbA1c, OGTT, Insulin, PTH, GH, Calcitonin, TFT, Testosterone, LH, FSH, Estrogen, Progestrone, PRL.
To start immunotherapy, at least 4 weeks must have passed since the last course of chemotherapy or radiotherapy, and all the side effects of chemotherapy must be eliminated.
Functional condition according to Karnowski criteria should be more than 60%
Expected survival rate more than 6 months

Exclusion Criteria

brain metastasis
autoimmune diseases
Abnormal function of heart, liver, kidney, brain and other important organs

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Side effect. Timepoint: 7 days. Method of measurement: clinical measurement.
Secondary Outcome Measures
NameTimeMethod
Clinical and immune response. Timepoint: one year. Method of measurement: Flow cytometry - ELISA - Overall survival rate - Tumor-free survival rate.
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