Camrelizumab Combined With Apatinib Mesylate

Solid Tumor Clinical Trial

Official title:

A Real World Study of Camrelizumab Combined With Apatinib Mesylate in Solid Tumors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05380986
• Other study ID #: SHR-1210-RWS
• Status: Recruiting
• Phase: N/A
• Start date: May 20, 2022
• Est. completion date: May 1, 2025

Study information

• Verified date: May 2022
• Source: Henan Cancer Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to observe the safety of camrelizumab combined with apatinib mesylate in the treatment of solid tumors

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: May 1, 2025
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Solid Tumor

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
China	Henan Tumor Hospital	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Henan Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AE	any adverse medical event that occurs after a subject or clinical study receives a drug or treatment regimen	up to 2 years
Secondary	Objective response rate	Defined as the proportion of patients with a documented complete response, and partial response (CR+PR)	up to 2 years
Secondary	Disease control rate	defined as the proportion of patients with complete response, partial response and disease stabilization (CR+PR+SD)	up to 2 years
Secondary	Overall survival	Overall survival	up to 2 years