Solid Tumor
Conditions
Brief summary
The purpose of this study is to observe the safety of camrelizumab combined with apatinib mesylate in the treatment of solid tumors
Detailed description
According to current studies, the combination of camrelizide and apatinib mesylate has significant efficacy and controllable toxicity in the treatment of solid tumors. This study adopted camrelizumab combined with apatinib mesylate in the treatment of solid tumors, aiming to further explore the safety of camrelizumab combined with apatinib mesylate in the treatment of solid tumors and provide more research data for the treatment of solid tumors.
Interventions
DRUGCamrelizumab combined with apatinib mesylate
Camrelizumab 200 mg, IVGTT D1, apatinib mesylate, once daily. The specific prescription is determined by the investigator. Continued use until disease progression, unacceptable toxicity, or withdrawal for other reasons.
Sponsors
Henan Cancer Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age: ≥18 years old, male or female; 2. ECOG score is 0\ 2; 3. Patients with solid tumors confirmed by pathology or histology; 4. At least one measurable lesion (according to RECIST V 1.1); 5. For patients who have failed first-line or second-line treatment or who cannot tolerate standard treatment regimens for solid tumors. 6. Estimated survival ≥3 months; 7. Patients who have used immunosuppressants or antiangiogenic drugs in the past are not excluded; 8. For women who have not undergone menopause or surgical sterilization, agree to abstain from sex or use an effective contraceptive method during treatment and for at least 7 months after the last dose given in study treatment; 9. Researchers think they can benefit; 10. Voluntarily participate in the study and sign the informed consent;
Exclusion criteria
1. Pregnant or lactating women; 2. Except patients with contraindications to camrelizumab and/or apatinib mesylate, that is, those allergic to camrelizumab and its excipients; Allergic to apatinib mesylate should be prohibited; It should be contraindication for patients with active bleeding, ulcers, intestinal perforation, intestinal obstruction, hypertension beyond drug control within 30 days after major surgery, class III-IV cardiac insufficiency (NYHA standard), and severe hepatic or renal insufficiency (Class 4). 3. Those deemed unsuitable for inclusion by doctors; 4. The researchers determined there was a high risk that the tumor would invade important blood vessels and cause fatal hemorrhages during the follow-up study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AE | up to 2 years | any adverse medical event that occurs after a subject or clinical study receives a drug or treatment regimen |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate | up to 2 years | Defined as the proportion of patients with a documented complete response, and partial response (CR+PR) |
| Disease control rate | up to 2 years | defined as the proportion of patients with complete response, partial response and disease stabilization (CR+PR+SD) |
| Overall survival | up to 2 years | Overall survival |
Countries
China
Outcome results
None listed