Advanced malignancy
Conditions
Interventions
Case series:sintilimab as a single agent or combination regimen
Sponsors
Yanshi People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. For different cohorts: Cohort A: Patients with locally advanced or metastatic NSCLC who have been confirmed by cytology or histology as inoperable or concurrent radiotherapy and chemotherapy, meet any of the following criteria: 1) Have not previously received systemic treatment for advanced or metastatic disease, except for patients with known EGFR sensitive mutations and ALK rearrangements; 2) After the failure of first-line platinum dual-drug chemotherapy; 3) Patients with known EGFR sensitive mutations or ALK rearrangements must have received at least one EGFR or ALK inhibitor treatment progression or intolerance; Cohort B: Patients with inoperable locally advanced, recurrent/metastatic gastric or gastroesophageal junction adenocarcinoma confirmed by cytology or histology, meeting any of the following criteria: 1) Locally advanced, recurrent or metastatic gastric and gastroesophageal junction adenocarcinoma (including signet ring cell carcinoma, mucinous adenocarcinoma, liver-like adenocarcinoma) that is newly diagnosed as unresectable, except for patients diagnosed as HER2-positive; 2) Unresectable or metastatic gastric/esophageal junction cancer with high microsatellite instability (MSI-H) or mismatch repair defect (dMMR) that has progressed after frontline treatment; 3) Locally advanced, recurrent or metastatic gastric and gastroesophageal junction adenocarcinoma that failed the second-line standard treatment, and PD-L1 CPS>1; Cohort C: Inoperable locally advanced recurrent or metastatic esophageal squamous cell carcinoma, meeting all the following criteria: 1) The previous first-line standard treatment failed; 2) Known endoscopes that tend to be completely obstructed and require interventional therapy to relieve the obstruction cannot be included; 3) After stent implantation in the esophagus or trachea, it cannot be included; 4) Patients who have a higher risk of bleeding or perforation due to the obvious invasion of the tumor into the adjacent organs of the esophageal lesion (aorta or trachea), or those who have formed a fistula, are not eligible; Cohort D: Inoperable patients with locally advanced, recurrent/metastatic hepatocellular carcinoma, the diagnosis of hepatocellular carcinoma is confirmed by histology/cytology or the patients with liver cirrhosis meet the clinical diagnosis of American Society for the Study of Liver Diseases (AASLD) hepatocellular carcinoma standard. Meet any of the following criteria: 1) Barcelona Clinic Liver Cancer (BCLC) staging is stage C; stage B is not suitable for radical surgery and/or local treatment; has not received systemic anti-tumor therapy for hepatocellular carcinoma in the past (postoperative Adjuvant chemotherapy is allowed to enter the group for more than 6 months); 2) HCC patients after failure of first-line systemic standard treatment; 2. Aged >=18 years old; 3. The expected survival time >=12 weeks; 4. According to the Curative Effect Evaluation Standard for Solid Tumors Version 1.1 (RECIST v1.1), there is at least one measurable or evaluable lesion; 5. According to the Eastern Cooperative Oncology Group's physical status score (ECOG PS score) 0-2 points; 6. Sintilizumab is included in the planned treatment regimen; 7. Possess sufficient organ and bone marrow function, defined as follows: 1) Blood routine: absolute neutrophil count >=1.5x10^9/L; platelet count >=100x10^9/L; hemoglobin content >=9.0 g/dL; 2) Liver function: serum total bilirubin
Exclusion criteria
Exclusion criteria: 1. Received live attenuated vaccine within 4 weeks before enrollment or plan to receive live attenuated vaccine during the study period; 2. Active, known or suspected autoimmune diseases; 3. Known history of primary immunodeficiency; 4. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation; 5. Female patients who are pregnant or breastfeeding; 6. Untreated acute or chronic active hepatitis B or C infection. In the case of patients receiving antiviral therapy, the doctor will judge whether they are eligible for enrollment according to the individual conditions of the patient while monitoring the virus copy number; 7. Uncontrolled concurrent diseases, including but not limited to: 1) HIV-infected persons (HIV antibody positive); 2) Serious infections that are active or poorly clinically controlled; 3) There are serious or uncontrollable systemic diseases (such as severe mental, neurological, epilepsy or dementia, unstable or uncompensated respiratory, cardiovascular, liver or kidney diseases, uncontrolled hypertension [ie refers to After drug treatment, it is still greater than or equal to CTCAE Grade 2 hypertension]) evidence; 4) Those with active bleeding or new thrombotic diseases who are taking a therapeutic amount of anticoagulants or have bleeding tendency.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Countries
China
Contacts
Public ContactHaifeng Bao
Department of Oncology, People's Hospital of Yanshi City
Outcome results
None listed