Treatment naive, advanced gastric cancer patients who have local advanced unresectable disease or distant metastasis with HER2 negative and PD-L1 positive expression
Conditions
Interventions
Study group:None
Sponsors
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Age >= 18 years, male or female; 2.Histologically confirmed gastric or gastroesophageal junction adenocarcinoma; 3.MSS/pMMR, HER2 negative, with result of PD-L1 expression, and record Claudin18.2 status; 4.Local advanced unresectable disease, or with distant metastasis, at least 1 measurable lesion; 5.Previously untreated, or disease progression more than 6 months after the completion of adjuvant therapy; 6.Assessed as the benefit group by the clinical prediction model using the following formula: Logit(P) = 1.407 - 0.055×SMRA - 0.397×NLR - 0.749×weight loss (=5%=1), Logit(P) = 3 months; 8.Adequate organ function to tolerate standard first-line chemotherapy combined with immunotherapy, and stable HBV infection; 9.Signed informed consent form, good compliance, and able to cooperate with related examinations, treatment, and follow-up.
Exclusion criteria
Exclusion criteria: 1.Pregnant or breastfeeding women; 2.Symptomatic metastases of central nervous system, uncontrollable pleural and abdominal effusion; 3.Other primary malignancies; 4.Contraindications for chemotherapy or immunotherapy; 5.Other conditions that patients are unsuitable for this study assessed by the investigators;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Progression-free survival;Disease control rate;Immune-related adverse event; | — |
Countries
China
Contacts
Public ContactZhou Chenfei
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Outcome results
None listed