Camrelizumab Combined With Apatinib Mesylate

NCT05380986 | Unknown

• 1 other identifier: SHR-1210-RWS
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Solid Tumor

Outcome Measures

Primary Outcomes (1)

• AE

  any adverse medical event that occurs after a subject or clinical study receives a drug or treatment regimen

  up to 2 years

Secondary Outcomes (3)

• Objective response rate

  up to 2 years

• Disease control rate

  up to 2 years

• Overall survival

  up to 2 years

Study Arms (1)

Camrelizumab combined with apatinib mesylate

EXPERIMENTAL

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

Interventions

Camrelizumab combined with apatinib mesylate 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.

Camrelizumab combined with apatinib mesylate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: ≥18 years old, male or female;
• ECOG score is 0\~2;
• Patients with solid tumors confirmed by pathology or histology;
• At least one measurable lesion (according to RECIST V 1.1);
• For patients who have failed first-line or second-line treatment or who cannot tolerate standard treatment regimens for solid tumors.
• Estimated survival ≥3 months;
• Patients who have used immunosuppressants or antiangiogenic drugs in the past are not excluded;
• 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;
• Researchers think they can benefit;
• Voluntarily participate in the study and sign the informed consent;

You may not qualify if:

• Pregnant or lactating women;
• 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).
• 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

Sponsors & Collaborators

• Henan Cancer Hospital: lead

Study Sites (1)

Henan Tumor Hospital

Henan, China

RECRUITING

MeSH Terms

Interventions

apatinib

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Chief Physician

Study Record Dates

• First Submitted: May 10, 2022
• First Posted: May 19, 2022
• Study Start: May 20, 2022
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2025
• Last Updated: May 19, 2022

Record last verified: 2022-05

Locations

CN (1)