Camrelizumab Combined With Apatinib Mesylate

Not Applicable

Recruiting

• Conditions: Solid Tumor
• Interventions: Drug: Camrelizumab combined with apatinib mesylate

• Registration Number: NCT05380986
• Lead Sponsor: Henan Cancer Hospital

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.

Study Timeline

• Status Verified: 2022-05
• Study First Submitted: 2022-05-10
• Study First Submitted QC: 2022-05-15
• Last Update Submitted: 2022-05-15
• Study First Posted: 2022-05-19
• Last Update Posted: 2022-05-19
• Study Start: 2022-05-20
• Primary Completion: 2024-05-01
• Study Completion: 2025-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Camrelizumab combined with apatinib mesylate	Camrelizumab 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.

Primary Outcome Measures

Name	Time	Method
AE	up to 2 years	any adverse medical event that occurs after a subject or clinical study receives a drug or treatment regimen

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Henan Tumor Hospital; 🇨🇳 Henan, China