gastric and gastroesophageal junction adenocarcinoma
Conditions
Interventions
Experimental Group:Immunotherapy combined with chemotherapy
Sponsors
Nanping First Hospital Affiliated to Fujian Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Unresectable locally advanced, recurrent or metastatic adenocarcinoma of the stomach and gastroesophageal junction (including signet ring cell carcinoma, mucinous adenocarcinoma, and hepatoid adenocarcinoma) confirmed by histopathological examination; 2. Aged 18 to 75 years; 3. ECOG PS score is 0-1 points; 4. The end time of previous (new) adjuvant chemotherapy/adjuvant radiotherapy was 6 months from > at the time of disease recurrence; 5. The end time of palliative treatment for local lesions (non-target lesions) was 2 weeks after the first treatment; 6. According to RECIST V1.1, there is at least one measurable lesion or assessable lesion; 7. Full organ and bone marrow function, defined as follows: Blood routine: absolute neutrophil count >= 1.5 x 10^9/L; Platelet count >= 100 x 10^9/L; Hemoglobin content >=9.0 g/dL; Liver function: serum total bilirubin (TBil) = 50mL/min; Urine dipstick test results showed urine protein 12 weeks; 9. For female subjects of reproductive age or male subjects whose sexual partner is a female of reproductive age, effective contraception should be used throughout the treatment period and up to 6 months after the treatment period (see Section 4.3); 10. Signed written informed consent and was able to comply with the program visits and related procedures.
Exclusion criteria
Exclusion criteria: 1. Live attenuated vaccine received within 4 weeks prior to enrolment or during the study period; 2. Active, known or suspected autoimmune diseases; 3. A known history of primary immunodeficiency; 4. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation; 5. Pregnant or breastfeeding female patients; 6. Untreated patients with acute or chronic active hepatitis B or C. Patients receiving antiviral treatment will be assessed by the physician on the basis of individual patient conditions while the copy number of the virus is monitored; 7. Uncontrolled concurrent diseases, including but not limited to: (1) HIV infection (HIV antibody positive); (2) Severe infections that are active or poorly controlled clinically; (3) Evidence of a serious or uncontrolled systemic disease (such as severe mental, neurological, epilepsy or dementia, unstable or uncompensated respiratory, cardiovascular, liver or kidney disease, uncontrolled hypertension (i.e., hypertension greater than or equal to CTCAE grade 2 after medication), have active bleeding or new thrombotic disease is taking therapeutic amount of anticoagulant drugs or have bleeding tendency.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival;Incidence of postoperative liver metastasis; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Unplanned Secondary Surgery; | — |
Countries
China
Contacts
Public ContactChen Shengchi
Nanping First Hospital Affiliated to Fujian Medical University
Outcome results
None listed