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Clinical study of Camrelizumab combined with Apatinib mesylate and chemotherapy in patients with advanced lung adenocarcinoma

Clinical study of Camrelizumab combined with Apatinib mesylate and chemotherapy in patients with advanced lung adenocarcinoma

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000034597
Enrollment
Unknown
Registered
2020-07-11
Start date
2020-07-12
Completion date
Unknown
Last updated
2020-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced lung adenocarcinoma

Interventions

Case series:Camrelizumab combined with Apatinib mesylate and chemotherapy

Sponsors

The First Affiliated Hospital of University of Science and Technology of China
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Aged >=18 years old; 2. Patients with advanced lung adenocarcinoma (stage IIIB-IV) confirmed by histopathology or cytology; 3. According to RECIST v1.1 standard, patients with measurable target lesions by CT or MRI examination. The imaging evaluation was performed within 28 days before the first administration; 4. Patients who have relapsed or failed to receive platinum based dual drug combination chemotherapy. The definition of "treatment failure": disease progression during treatment or after the last treatment must have clear evidence of imaging or clinical progress. 5. Patients with negative EGFR, ALK and ros1 mutations; 6. ECoG PS score: 0-1; 7. Patients who volunteered to join the study signed informed consent and had good compliance, and cooperated with follow-up; 8. The researchers believe that patients can benefit.

Exclusion criteria

Exclusion criteria: 1. Excluding patients without measurable lesions; 2. Patients who have been proved to be allergic to the test drug and / or its excipients; 3. Patients with brain metastasis or meningeal metastasis with clinical symptoms. Patients with brain metastases after treatment need to meet the following conditions: no progress demonstrated by MRI at least 4 weeks after the end of treatment, treatment completed within 28 days before the first dose of study drug, and no systemic corticosteroid therapy (> 10mg / day prednisone or equivalent dose) was required before = 14 days before the first dose of study drug; 4. Patients with interstitial pneumonia (ILD), drug-induced pneumonia, radiation-induced pneumonia requiring steroid therapy, or active pneumonia with clinical symptoms or severe pulmonary dysfunction; 5. Patients with heart clinical symptoms or diseases that are not well controlled, such as: (1) NYHA grade 2 and above heart failure (2) Unstable angina pectoris (3) Myocardial infarction occurred within 24 weeks (4) Clinically significant supraventricular or ventricular arrhythmias need treatment or intervention; 6. Patients who have previously received any T-cell costimulation or immune checkpoint therapy, including but not limited to cytotoxic T lymphocyte associated antigen-4 (CTLA-4) inhibitors, PD-1 inhibitors, PD-L1 / 2 inhibitors, or other drugs targeting T cells; 7. Patients with any immunodeficiency disease or history, or with a history of organ transplantation; 8. Pregnant or lactating women; 9. According to the judgment of the researcher, the patients who are not suitable to be included in this study.

Design outcomes

Primary

MeasureTime frame
Progression-free survival;Overall survival;

Secondary

MeasureTime frame
Objective response rate;Desease control rate;Duration of remission;Adverse event;

Countries

China

Contacts

Public ContactPan Yueyin

The First Affiliated Hospital of University of Science and Technology of China

panyueyin@ustc.edu.cn+86 13805695536

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 15, 2026