Her2-positive advanced colorectal cancer
Conditions
Interventions
Pyrrotinib combined with trastuzumab:oral Pyrrotib maleate tablets, initial dose 400 mg/day, taken within 30 min after breakfast, once a day, continuous administration, 21 days per cycle. Trastuzumab
Pyrrotinib alone:Oral Pyrrotib maleate tablets by initial dose of 400 mg/day, taken within 30 min after breakfast, once a day, continuous administration, 21 days per treatment cycle.
Sponsors
Cancer Hospital Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18 years old or above, male or female; 2. Histopathologically or cytologically confirmed HER2 positive (immunohistochemical (IHC) score 3+ or 2+ confirmed by pathology laboratory and positive in situ hybridization (ISH) test)) for advanced colorectal cancer; 3. Two previous systemic chemotherapy regimens for colorectal cancer were ineffective or advanced; 4. ECOG PS score 0-2; 5. Expected survival >=3 months; 6. There were measurable lesions conforming to RECIST 1.1; 7. The main organs are functioning normally, and the laboratory examination meets the following requirements: (1) blood routine examination standards should meet: HB>=90 g/L(no transfusion within 14 days); the ANC acuity 1.5x10^9/L; PLT acuity 80x10^9/L; (2) Biochemical examination should meet the following criteria: TBIL 50 ml/min(Cockcroft-Gault formula); (3) Cardiac color doppler ultrasound LVEF>=50%; 8. Women of child-bearing age shall have a negative pregnancy test (serum or urine) result within 7 days prior to enrollment and shall voluntarily use the appropriate method of contraception during the observation period and within 12 weeks after the last dose of the study drug;For men, surgical sterilization or consent to appropriate methods of contraception during the observation period and within 12 weeks of the last administration of the study drug should be undertaken; 9. Patients voluntarily participate in the study and sign the informed consent (ICF); 10. Patients with compliance are expected to follow up the efficacy and adverse reactions as required by the program.
Exclusion criteria
Exclusion criteria: 1. Other malignant tumors have been diagnosed within 5 years before the first use of the study drug, except basal cell carcinoma of the skin, squamous cell carcinoma of the skin and/or in-situ cervical cancer and/or breast cancer that have been effectively treated; 2. Symptomatic central nervous system metastasis; 3. Known allergy to pyrrotinib or trastuzumab or pharmaceutical excipients; 4. Received pyrrotinib, trastuzumab or other anti-her2 drugs; 5. There are various factors affecting the absorption of oral drugs, such as inability to swallow, nausea and vomiting, chronic diarrhea and intestinal obstruction; 6. Has failed to control the heart of the clinical symptoms or disease, including but not limited to congestive heart failure (NYHA classification >II level);Unstable or severe angina;Acute myocardial infarction occurred within 6 months;Patients with clinically significant supraventricular or ventricular arrhythmias that require clinical intervention; 7. Participate in other clinical trials or participate in any other clinical study of drugs within 4 weeks, or use drugs less than 5 half-lives from the last study; 8. Use an inhibitor or inducer of the isoenzyme CYP3A4 within 14 days before the study begins; 9. Other conditions considered inappropriate for inclusion by the researcher.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease Control Rate;Progression-Free Survival;overall survival;adverse event; | — |
Countries
China
Contacts
Public ContactYongkun Sun
National Cancer Center/Cancer Hospital Chinese Academy of Medical Sciences and Peking Union Medical College
Outcome results
None listed