This study is a prospective, observational, real-world, multi-center study planning to enroll 90 patients. The study will observe and document patients' actual clinical practices in receiving Iparomlimab and Tuvonralimab Injection (QL1706). The primary objectives are to evaluate the safety and effectiveness of Iparomlimab and Tuvonralimab Injection (QL1706) in treating locally advanced or metastatic solid tumors.
1) Histologically or cytologically confirmed locally advanced or metastatic solid tumors with disease progression (radiographic or clinical) after ≥1 line of prior standard therapy, unsuitable for/intolerant to standard therapy. Includes but not limited to: Gastrointestinal tumors (colorectal cancer, hepatocellular carcinoma, esophageal cancer, biliary tract cancer, pancreatic cancer, gastric cancer), Breast cancer, Non-small cell lung cancer (NSCLC), Small cell lung cancer (SCLC), Soft tissue sarcoma;
2) ECOG performance status 0-2;
3) ≥1 measurable lesion per RECIST v1.1 ;
5) Life expectancy ≥12 weeks;
1) Tumor-Related Conditions
Known CNS metastases (except those radiologically stable ≥4 weeks after radiotherapy);
Uncontrolled effusions requiring recurrent drainage (pleural/pericardial/ascites), per investigator assessment.
2) Prior Anti-tumor Therapy
Histologically or cytologically confirmed locally advanced or metastatic solid tumors with disease progression (radiographic or clinical) after ≥1 line of prior standard therapy, unsuitable for/intolerant to standard therapy.
Cohort
Prospective
Observation arm
DrugTo observe the efficacy and safety of Iparomilimab and Tuvonralimab in the treatment of patients with solid tumors in the real world
Incidence of Grade ≥3 irAEs
Incidence of adverse events
Incidence of treatment-related adverse events
Incidence of immune-related adverse events
Objective response rate
Overall Survival
Progression-Free Survival
Disease Control Rate
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PENG YUAN
Lead sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Sponsor institution
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