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An exploratory clinical study of Camrelizumab combined with nab-paclitaxel second-line and above in the treatment of small cell lung cancer

An exploratory clinical study of Camrelizumab combined with nab-paclitaxel second-line and above in the treatment of small cell lung cancer

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100048612
Enrollment
Unknown
Registered
2021-07-11
Start date
2021-07-15
Completion date
Unknown
Last updated
2022-03-21

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

Conditions

small cell lung cancer

Interventions

Case series:camrelizumab combined with chemotherapy

Sponsors

the Affiliated Cancer Hospital of Harbin Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Pathologically confirmed patients with advanced small cell lung cancer who have recurred and or progressed; 2. Have received at least one systemic treatment in the past; 3. Have measurable tumor lesions (spiral CT scan 10mm, meet RECIST 1.1 standard); 4. Expected survival time> 3 months; 5. Age >=18 years old; 6. ECOG PS: 0-2 points; 7. The functions of vital organs meet the following requirements: (1) Absolute neutrophil count >=1.5x10^9/L, platelet >=100x10^9/L, hemoglobin >=9g/dL; (2) Bilirubin 60 mL/min; 8. Women of childbearing age must have a negative pregnancy test (beta HCG) before starting treatment. Women and men of childbearing age (have sex with women of childbearing age) must agree to use effective contraception during treatment and 6 months after the last treatment dose; 9. The patient voluntarily joined the study and signed an informed consent form.

Exclusion criteria

Exclusion criteria: 1. Suffered from other malignant tumors in the past or at the same time, except for cured skin basal cell carcinoma and cervical carcinoma in situ; 2. There is active tuberculosis infection. Patients with active pulmonary tuberculosis infection within 1 year before the medication should be excluded even if they have been treated.Patients with a history of active pulmonary tuberculosis infection more than 1 year ago are also excluded, unless it is proven that they have previously received standard anti-tuberculosis treatment; 3. Those who have not effectively controlled, symptomatic brain metastases or have a history of uncontrollable mental illness or have severe intellectual or cognitive dysfunction; 4. Subjects with active, known or suspected autoimmune diseases, hypothyroidism that only needs hormone replacement therapy, skin diseases that do not require systemic treatment (such as vitiligo, psoriasis, or hair loss) can be selected; 5. Congestive heart failure, uncontrollable arrhythmia, myocardial infarction, unstable angina, stroke or transient ischemic attack within 6 months; 6. Patients who cannot comply with the trial protocol or cannot cooperate with follow-up; 7. There is a history of psychotropic drug abuse, alcohol or drug abuse; 8. Human immunodeficiency virus (HIV, HIV 1/2 antibody) positive; 9. The researcher thinks it is inappropriate to participate in this experiment.

Design outcomes

Primary

MeasureTime frame
objective response rate;

Secondary

MeasureTime frame
disease control rate;progression-free survival;overall survival;

Countries

China

Contacts

Public ContactWang Xiaohong

the Affiliated Cancer Hospital of Harbin Medical University

851539995@qq.com+86 13303602615

Outcome results

None listed

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