Camrelizumab Combined With Apatinib Mesylate

NCT ID: NCT05380986

Last Updated: 2022-05-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-20
• Study Completion Date: 2025-05-01

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.

Conditions

Solid Tumor

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Camrelizumab combined with apatinib mesylate

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Henan Cancer Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

LiNing

Associate Chief Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Henan Tumor Hospital

Henan, , China

Site Status: RECRUITING

Countries

China

Facility Contacts

LI NING, Doctor

Role: primary

lining97@126.com

13526501903

Other Identifiers

SHR-1210-RWS

Identifier Type: -

Identifier Source: org_study_id