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A prospective, single arm, multicenter clinical trial of Pyrotinib combined with Bevacizumab and Capeox regimen in the treatment of advanced HER2-positive colorectal cancer

A prospective, single arm, multicenter clinical trial of Pyrotinib combined with Bevacizumab and Capeox regimen in the treatment of advanced HER2-positive colorectal cancer

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100043766
Enrollment
Unknown
Registered
2021-02-28
Start date
2021-03-01
Completion date
Unknown
Last updated
2021-06-28

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

Conditions

advanced HER2-positive colorectal cancer

Interventions

Case series: Pyrotinib combined with Bevacizumab and Capeox regimen

Sponsors

Jiangsu Province Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Patients who met the following criteria were included in this observational study after taking pyrrolidine: 1. Between 18 and 75 years old, male and female; 2. ECOG score was 0 - 1; 3. First line patients with advanced HER2-positive colorectal cancer who had received irinotecan treatment; 4. HER2 positive was defined as: (1) IHC 3+: more than 50% of the tumor cells showed strong positive at the base and side of the cell membrane or the whole cell membrane; (2) Patients with HER2 score of 2+ should be detected by fish to further clarify the HER2 gene status; (3) Positive amplification of HER2 gene: more than 50% of tumor cells with HER2 / CEP17 ratio >= 2.0. 5. According to RECIST 1.1, there was at least one measurable target lesion; 6. The functional level of main organs must meet the following requirements (no blood transfusion, no use of leukocyte and platelet raising drugs within 2 weeks before screening): (1) Blood routine: neutrophil (ANC) >=1.5 x 10^9/L; platelet count (PLT) >= 90 x 10^9/L; hemoglobin (HB) >= 90 g / L; (2) Blood biochemistry: total bilirubin (TBIL) = 55%; 7. Informed consent was signed to collect the clinical efficacy and information of patients.

Exclusion criteria

Exclusion criteria: 1) In the stage of adjuvant therapy, the interval from the end of oxaliplatin based treatment to the detection of recurrence / metastasis was less than 6 months; 2) The third space effusion (such as pleural effusion and ascites) which can not be controlled by drainage or other methods cannot be evaluated; 3) Those who have a history of psychotropic drug abuse and can not give up or have mental disorders; 4) Pregnant or lactating women; patients with fertility are unwilling or unable to take effective contraceptive measures; 5) The patient has serious accompanying disease or the researcher thinks it is not suitable to participate in this study; 6) Previous clinical use of Pyrotinib was not included in this study.

Design outcomes

Secondary

MeasureTime frame
Progression free survival;Disease control rate;Overall survival;Duration of remission;Security;

Primary

MeasureTime frame
Objective remission rate;

Countries

China

Contacts

Public ContactYanhong Gu

Jiangsu Province Hospital

guluer@163.com+86 13813908678

Outcome results

None listed

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