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The clinical study of camrelizumab combined with CAPEOX regimen in the first-line treatment of advanced colorectal cancer

The clinical study of camrelizumab combined with CAPEOX regimen in the first-line treatment of advanced colorectal cancer - prospective, single-center, single-arm

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100049647
Enrollment
Unknown
Registered
2021-08-07
Start date
2021-08-01
Completion date
Unknown
Last updated
2022-04-19

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

Conditions

Colorectal cancer

Interventions

Experimental group:Carrelizumab + capecitabine + oxaliplatin

Sponsors

The Second Affiliated Hospital of Anhui Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-75 years, no gender limit; 2. Patients with recurrence after colorectal cancer resection or patients with advanced colorectal cancer who have not received any treatment before; 3. ECOG PS score 0-1 points; 4. Estimated survival period >=12 months; 5. The main organ functions are normal, and there are no patients with severe blood, heart, lung, liver, kidney, bone marrow and other dysfunctions and immunodeficiency. The laboratory inspection meets the following requirements: (1) Hemoglobin (Hb) >=90 g/L; (2) White blood cell (WBC) >=3.0x10^9/L; Neutrophil count (NEUT) >=1.5x10^9/L; (3) Platelets (PLT) >=100x10^9/L; (4) Liver function (aspartate aminotransferase AST or alanine aminotransferase ALT) level <=2.5 ULN; renal function (serum creatinine sCr) level <=1.5 ULN; (5) Total bilirubin (TBIL) <=1.5 ULN; (6) Urine protein, urine occult blood <2+; fecal occult blood <2+; 6. Patients voluntarily join the study, sign an informed consent form, have good compliance, and cooperate with follow-up; 7. The investigator believes that the treatment can benefit.

Exclusion criteria

Exclusion criteria: 1. Those who have been confirmed to be allergic to the test drug and/or its excipients; 2. Subjects who have received or are receiving additional chemotherapy, radiotherapy, targeted or immunotherapy; 3. Suffer from any active autoimmune disease or history of autoimmune disease; 4. Suffer from congenital or acquired immune function defects, such as human immunodeficiency virus (HIV) infection, active hepatitis B (HBV DNA >=500 IU/mL), hepatitis C (hepatitis C antibody positive, and high HCV-RNA (Under the detection limit of the analytical method) or co-infection with hepatitis B and C; or a history of organ transplantation; 5. Cardiac clinical symptoms or diseases that are not well controlled, such as: (1) Heart failure above NYHA level 2; (2) Unstable angina; (3) Myocardial infarction within 1 year; 6. Pregnant or lactating subjects; 7. According to the judgment of the investigator, subjects who are not suitable for inclusion in this study; 8. Those who have medical systemic diseases and psychiatric diseases that are not suitable for chemotherapy; 9. Those who have acute infection and need antibiotic treatment; 10. Subjects who have participated in other drug clinical trials within four weeks.

Design outcomes

Primary

MeasureTime frame
progression-free survival;

Countries

China

Contacts

Public ContactYu Gang

The Second Affiliated Hospital of Anhui Medical University

yugang1189@sina.cn+86 15156995163

Outcome results

None listed

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