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A prospective, single-arm, single-center clinical study for Camrellizumab combined with EP in the first-line treatment of Extensive small cell lung cancer

A prospective, single-arm, single-center clinical study for Camrellizumab combined with EP in the first-line treatment Extensive small cell lung cancer

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000031989
Enrollment
Unknown
Registered
2020-04-17
Start date
2020-06-01
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

small cell lung cancer

Interventions

Case series:camrelizumab combined with EP

Sponsors

Chongqing Three Gorges Center Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. patients with a wide range of small cell lung cancer diagnosed by histology or cytology; 2. aged 18-75 years; 3. PS score 0-1; 4. has at least one evaluable lesion; 5. asymptomatic patients with brain metastases, symptomatic patients with brain metastases can enter the group after the control of brain metastases symptoms; 6. expected survival >=12 weeks; 7. blood routine examination: ANC>=1.5x10^9/L, PLT>=80x10^9/L, Hb>=90g/L (no blood transfusion and blood products within 14 days, no use of G-CSF and other hematopoietic stimulation factor correction); 8. Biochemical examinationTBIL=50ml/min(Cockcroft-Gault formula); 9. women of childbearing age must have taken reliable contraception or have a pregnancy test (serum or urine) conducted within 7 days before entering the group, with negative results, and are willing to use appropriate methods of contraception during the trial and 8 weeks after the last administration of the test drug; 10. Participants volunteered to join the study, with good compliance and follow-up.

Exclusion criteria

Exclusion criteria: 1. underwent major surgery within 28 days prior to random allocation or is expected to undergo major surgery during the study period; 2. suffering from severe cardiovascular disease; 3. Abdominal fistula, gastrointestinal perforation, or abdominal abscess occurred within 6 months before the 3. group; 4. untreated patients with active hepatitis; 5. confirmed allergy to research drugs and/or their excipients; 6. patient has any active autoimmune disease or history of autoimmune disease; 7. have received hematopoietic stem cells or any organ transplant; 8. severe allergic reaction to other monoclonal antibodies; 9. Pregnant or lactating women; persons with fertility who are unwilling or unable to use effective contraception; 10. Persons with a history of substance abuse and who are unable to control it or have mental disorders 11. The researchers judge other situations that may affect the conduct of clinical studies and the determination of their findings.

Design outcomes

Primary

MeasureTime frame
PFS;

Secondary

MeasureTime frame
OS;ORR;DCR;QoL;Adverse events;

Countries

China

Contacts

Public ContactBiyongRen

Chongqing Three Gorges Center Hospital

biyou@sina.com+86 13896327099

Outcome results

None listed

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