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A clinical study of camrelizumab combined with thalidomide for the treatment of a variety of solid tumors that have previously received first-line and (or) second-line chemotherapy failure

A clinical study of camrelizumab combined with thalidomide for the treatment of multiple solid tumors that have previously failed first-line and/or second-line chemotherapy: prospective, interventional, one-arm study

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100052588
Enrollment
Unknown
Registered
2021-11-01
Start date
2022-03-21
Completion date
Unknown
Last updated
2023-04-12

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

Conditions

Multiple solid tumors

Interventions

experimental group:Camrelizumab + Thalidomide

Sponsors

Lixin County People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Aged from 18 to 85 years, male or female; 2. Patients with advanced liver cancer, lung cancer, stomach cancer, colorectal cancer, esophageal cancer and other solid tumors who have previously received standard first-line and/or second-line systemic chemotherapy for disease progression or who cannot tolerate chemotherapy; 3.ECOG PS score 0-3; 4. Estimated survival >=3 months; 5. The main organs were functioning normally, and no patients with serious dysfunction of blood, heart, lung, liver, kidney, bone marrow or immune deficiency were found. The laboratory tests met the following requirements: (1) Hemoglobin >=75 g/L; (2) White blood cell >=3.0x10^9/L; Neutrophil count >=1.5x10^9/L; (3) Platelet >=70x10^9/L; (4) Liver function (ASpartate aminotransferase AST or ALT) <=2.5 times the upper limit of normal value (ULN); (5) Renal function (serum creatinine sCr) <=1.5 times the upper limit of normal value (ULN); (6) Total bilirubin (TBIL) <=1.5 times normal upper limit (ULN); (7) urinary protein and occult blood < 2+; Fecal occult blood < 2+. 6. Subjects voluntarily joined the study and signed informed consent with good compliance and follow-up; 7. Researchers believe that treatment can benefit.

Exclusion criteria

Exclusion criteria: 1. Persons who have been proved to be allergic to the test drug and/or its excipients; 2. Subjects who are receiving additional chemotherapy, radiation, targeted or immunotherapy; 3. Have any active autoimmune diseases or a history of autoimmune diseases; 4. Patients with congenital or acquired immune deficiency, such as human immunodeficiency virus (HIV) infection, active hepatitis B (HBV DNA>=500 IU/mL), hepatitis C (positive hepatitis C antibody, and HCV-RNA higher than the detection limit of analysis method) or co-infection with hepatitis B and hepatitis C; or have a history of organ transplantation; 5. Clinical symptoms or diseases of the heart that are not well controlled; 6. Pregnant or lactating women; 7. Men and women who attempted pregnancy within 4 weeks before and after oral thalidomide treatment; 8. Recent history of thrombosis; 9. Patients not suitable for inclusion in this study as judged by the investigator; 10. Patients with internal systemic diseases and psychiatric diseases are not suitable for chemotherapy; 11. Patients with acute infection requiring antibiotic treatment; 12. Patients who had participated in clinical trials of other drugs within four weeks.

Design outcomes

Primary

MeasureTime frame
progression-free survival;

Secondary

MeasureTime frame
overall survival;

Countries

China

Contacts

Public ContactZhao Dong

Lixin County People's Hospital

25538336@qq.com+86 18956867980

Outcome results

None listed

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