Gut Microbial Metabolites Inosine Combined With PD-1/PD-L1 Inhibitor for Patients With Malignant Advanced Solid Tumors
Condition: Advanced Solid Tumor
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      We conducted a single-center, prospective randomized ,Parallel controls, open labels Clinical
      Studies,The study is about Gut Microbial Metabolites Inosine Combined With PD-1/PD-L1
      Inhibitor for Patients with malignant Advanced Solid Tumors .One group was the inosine group
      , the other group was the non-inosine group.The treatment regimen of inosine group : inosine
      + PD-1/PD-L1 inhibitor ± chemotherapy/targeting, and the treatment regimen of non-inosine
      group : PD-1/PD-L1 inhibitor ± chemotherapy/targeting.The primary study endpoints were
      overall survival (OS) and progression-free survival PFS, and the secondary study endpoints
      were objective remission rate (ORR) and disease control rate (DCR) comparing the two groups.
    

Detailed description: 
      We conducted a single-center, prospective randomized ,Parallel controls, open labels Clinical
      Studies,,The study is about Gut Microbial Metabolites Inosine Combined With PD-1/PD-L1
      Inhibitor for Patients with malignant Advanced Solid Tumors.One group was the inosine group ,
      the other group was the non-inosine group. A total of 172 patients with advanced malignant
      solid tumors were collected from Capital Medical University Beijing Friendship Hospital, and
      randomly assigned to two groups according to 1:1, 86 patients in the inosine group and 86
      patients in the non-inosine group. The regimen of inosine treatment group was: inosine +
      PD-1/PD-L1 inhibitor ± chemotherapy/targeting, and the treatment regimen of non-inosine
      treatment group was: PD-1/PD-L1 inhibitor ±chemotherapy/targeting,every 2 or 3 weeks protocol
      ,until the subject's disease progresses, death, intolerable adverse events, the investigator
      determines that there is no benefit from continued treatment or other termination criteria
      are met (pregnancy, individual patient reasons or co-morbidities), the subject requests
      withdrawal from the study, withdrawal of informed consent, and loss of visit.Anti-tumor
      efficacy is evaluated every 2/3 cycles (every 6 weeks) based on computed tomography (CT) or
      magnetic resonance imaging (MRI) results and their tumor markers, according to RECIST v1.1
      criteria.

      Inosine tablets were purchased from Tianjin Jinshi, dosage: 0.2g orally 3 times/day,
      PD-1/PD-L1 inhibitors, chemotherapy and targeted combination therapy regimens were developed
      by the investigators according to the NCCN guidelines and CSCO guidelines and the patient's
      condition and its staging.
    

Intervention name(s): Inosine 0.2g orally 3 times/day; PD-1/PD-L1 inhibitor ,chemotherapy/targeting
Intervention type(s): Drug; Drug
Intervention description(s): inosine + PD-1/PD-L1 inhibitor ± chemotherapy/targeting,; PD-1/PD-L1 inhibitor ± chemotherapy/targeting
Other intervention name(s): Camrelizumab for injection; Sintilimab injection; Penpulimab injection; Tislelizumab injection; Pembrolizumab injection; Toripalimab; Atezolizumab; chemotherapy/targeting; Camrelizumab for injection; Sintilimab injection; Penpulimab injection; Tislelizumab injection; Pembrolizumab injection; Toripalimab; Atezolizumab; chemotherapy/targeting
Intervention MeSH terms: Pembrolizumab; Atezolizumab; Tislelizumab; Immune Checkpoint Inhibitors; Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment