Camrelizumab Combined With Apatinib Mesylate

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

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

Study Overview

• Status: Recruiting
• Conditions: Solid Tumor
• Intervention / Treatment: Drug: Camrelizumab combined with apatinib mesylate

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 Type: Interventional
• Enrollment (Anticipated): 500
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Henan, China
    • Recruiting
    • Henan Tumor Hospital
    • Contact: LI NING, Doctor; Phone Number: 13526501903; Email: lining97@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AE	any adverse medical event that occurs after a subject or clinical study receives a drug or treatment regimen	up to 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective response rate	Defined as the proportion of patients with a documented complete response, and partial response (CR+PR)	up to 2 years
Disease control rate	defined as the proportion of patients with complete response, partial response and disease stabilization (CR+PR+SD)	up to 2 years
Overall survival	Overall survival	up to 2 years

Collaborators and Investigators

• Sponsor: Henan Cancer Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): May 20, 2022
• Primary Completion (Anticipated): May 1, 2024
• Study Completion (Anticipated): May 1, 2025

Study Registration Dates

• First Submitted: May 10, 2022
• First Submitted That Met QC Criteria: May 15, 2022
• First Posted (Actual): May 19, 2022

Study Record Updates

• Last Update Posted (Actual): May 19, 2022
• Last Update Submitted That Met QC Criteria: May 15, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Apatinib
• Other Study ID Numbers: SHR-1210-RWS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No