Digestive system solid tumor
Conditions
Interventions
Phase 1 :NA
Phase 2 :NA
Phase 3 :NA
Sponsors
Harbin Medical University Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Phase 1 advanced Gastric Cancer First-Line Treatment Cohort: 1. Age >= 18 years; 2. Histologically diagnosed with gastric cancer or gastroesophageal junction cancer, and PDL1 and CPS scores are known; 3. Advanced metastatic gastric cancer at stage IV, based on the 8th edition of the AJCC TNM staging system; 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1; 5. Not previously treated with systemic therapy (e.g., chemotherapy, anti-angiogenic drugs, targeted drugs, and immunotherapy); 6. Presence of at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1); 7. Monotherapy with PD-1/PD-L1 inhibitors or combination with chemotherapy; 8. Function of important organs meets the following requirements: 1) Absolute neutrophil count >= 1.5 x 10/L, platelets >= 100 x 10/L, hemoglobin >= 9 g/dL; 2) Bilirubin 60 mL/min. 9. Adequate hematological function, based on the laboratory criteria met within 7 days before the start of treatment: oa. Absolute neutrophil count (ANC) >= 1200/mm^3 (>= 1.2 x 10^9/L) ob. Platelets >= 60,000/mm3 (>= 60 x 10^9/L) oc. Hemoglobin >= 8 g/dL (>= 80 g/L) 10. Informed and willing to participate in the study; Phase 2 advanced esophageal cancer first-line treatment cohort: 1. Age >= 18 years; 2. Pathologically diagnosed as esophageal squamous cell carcinoma or esophageal adenocarcinoma and being distant metastatic esophageal cancer, with known PDL1 expression and CPS score; 3. At least one measurable lesion can be evaluated according to the RECIST 1.1 standard; 4. Has not received systemic treatment (such as chemotherapy, anti-angiogenic drugs, targeted drugs, and immunotherapy); 5. Received PD-1/PD-L1 inhibitor combined with chemotherapy as neoadjuvant treatment; 6. The function of important organs meets the following requirements: 1) Absolute neutrophil count >= 1.5 x 10/L, platelets >= 100 x 10/L, hemoglobin >= 9 g/dL; 2) Bilirubin 60 mL/min. 7. Sufficient hematological function, based on the laboratory standards met within 7 days before the start of treatment: oa. Absolute neutrophil count (ANC) >= 1200/mm^3 (>= 1.2 x 10^9/L) ob. Platelets >= 60,000/mm3 (>= 60 x 10^9/L) oc. Hemoglobin >= 8 g/dL (>= 80 g/L) 8. Informed and agreed to participate in the study. Phase 3 treatment cohort for advanced liver cancer: 1. Age >= 18 years old; 2. Child-Pugh overall score = 1200/mm^3 (>= 1.2 x 10^9/L); b. Platelets >= 60,000/mm3 (>= 60 x 10^9/L); c. Hemoglobin >= 8 g/dL (>= 80 g/L); 8. At least one measurable lesion that can be evaluated according to RECIST 1.1 criteria; 9. No pri
Exclusion criteria
Exclusion criteria: Phase 1 advanced Gastric Cancer First-Line Treatment Cohort: 1. MSI-H, pMMR or HER2 positive; 2. Suffering from other malignant tumors within the past 3 years; 3. Complicated with acute or chronic mental disorders; 4. Currently receiving antidepressant or anti-anxiety treatment; 5. Had received treatment in other clinical drug trials in the past; 6. Patients with symptomatic brain metastases; 7. Unable to cooperate with the assessment of psychological scales. Phase 2 advanced esophageal cancer first-line treatment cohort: 1. dMMR, MSI-H; 2. Having other malignant tumors within the past 3 years; 3. Concurrent acute or chronic mental disorders; 4. Currently undergoing treatment for depression or anxiety; 5. Previously received treatment in other clinical drug trials; 6. Unable to cooperate with psychological scale assessment. Phase 3 treatment cohort for advanced liver cancer: 1. dMMR, MSI-H; 2. Having other malignant tumors within the past 3 years; 3. Concurrent acute or chronic mental disorders; 4. Currently undergoing treatment for depression or anxiety; 5. Previously received treatment in other clinical drug trials; 6. Unable to cooperate with psychological scale assessment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Scale rating:Depressive state; anxiety symptoms; quality of life; | — |
Secondary
| Measure | Time frame |
|---|---|
| Serum cortisol and adrenocorticoid hormone (ACTH); | — |
Countries
China
Contacts
Public ContactLei Liu
Harbin Medical University Cancer Hospital
Outcome results
None listed