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An exploratory clinical study of karelizumab combined with chemotherapy in the treatment of lung cancer patients with inactive pulmonary tuberculosis

An exploratory clinical study of karelizumab combined with chemotherapy in the treatment of lung cancer patients with inactive pulmonary tuberculosis

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000041449
Enrollment
Unknown
Registered
2020-12-26
Start date
2020-12-30
Completion date
Unknown
Last updated
2021-03-15

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

Conditions

Lung cancer patients with inactive tuberculosis

Interventions

Sponsors

Heilongjiang Infectious Disease Prevention and Control Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. Patients with advanced lung cancer confirmed by pathology; 2. Patients with non active pulmonary tuberculosis diagnosed by imaging methods; 3. Patients whose sputum culture results were negative; 4. Patients with measurable tumor lesions (spiral CT scan >= 10 mm, meet RECIST 1.1 standard); 5. Patients with expected survival > 3 months; 6. Age: >= 18 years old, male or female; 7. Patients with ECoG PS: 0-2; 8. The functions of important organs meet the following requirements: (1) Absolute neutrophil count >= 1.5 x 10^9 / L, platelet count >= 100 x 10^9 / L, hemoglobin count >= 9g / dl; (2) Bilirubin 60 ml / min; 9. Women of childbearing age must have a negative pregnancy test (ß hCG) before treatment, and women of childbearing age and men (having sex with women of childbearing age) must agree to use effective contraceptives continuously during treatment and 6 months after the last dose of treatment; 10. The patients who voluntarily joined the study signed the informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with other malignant tumors in the past or at the same time, except the cured basal cell carcinoma of skin and carcinoma in situ of cervix; 2. Patients with uncontrolled, symptomatic brain metastases, uncontrollable psychiatric history, or severe intellectual or cognitive impairment; 3. Patients with active, known or suspected autoimmune diseases, hypothyroidism who only need hormone replacement therapy, and skin diseases (such as vitiligo, psoriasis or alopecia) who do not need systemic treatment can be included; 4. Patients with congestive heart failure, uncontrollable arrhythmia, myocardial infarction within 6 months, unstable angina pectoris, stroke or transient ischemic attack; 5. Patients who can not comply with the trial protocol or cooperate with the follow-up; 6. Patients with history of psychotropic drug abuse, alcoholism or drug abuse; 7. Human immunodeficiency virus (HIV, HIV 1 / 2 antibody) positive patients; 8. Subjects who are considered unsuitable to participate in this study.

Design outcomes

Primary

MeasureTime frame
objective response rate;

Secondary

MeasureTime frame
Disease control rate;Progression Free Survival;overall survival;Recovery rate of mycobacterium tuberculosis of sputum culture;safety;

Countries

China

Contacts

Public ContactChunli Wang

Heilongjiang Infectious Disease Prevention and Control Hospital

468942740@qq.com+86 13845140926

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026