Rectal cancer
Conditions
Interventions
Experimental group:Patients received trastuzumab biosimilar and pertuzumab biosimilar [trastuzumab biosimilar dose 8mg/kg, subsequent 6mg/kg, D1, Q3W
Pertuzumab biosimilar 840mg first dose followed by 420mg, D1, Q3W] combined with XELOX regimen [oxaliplatin 130mg/m2, D1, IV infusion + capecitabine 1000mg/m2, d1-14, twice a day, oral] every 3 weeks
Sponsors
Peking Union Medical College Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Age >=18; 2.Patients with histologically or cytologically confirmed rectal cancer; locally advanced (cT3/T4, N+, distance between the lower edge of the tumor and the anal verge =1.5×109/L (2) hemoglobin (Hb) >=90g/L (3) platelet >=100×109 /L (4) albumin >=30g/L (5) Serum creatinine 50 mL/min (calculated according to Cockcroft-Gault formula) (6) Total bilirubin <=1.5×ULN; (7) Alt, AST <=2.5×ULN, Alt, AST <=5×ULN in patients with liver metastasis; (8) activated partial thromboplastin time <=1.5×ULN; International normalized ratio <=1.5×ULN. 9. Eligible individuals (men and women) of childbearing potential had to agree to use a reliable method of contraception (hormonal contraceptives, barrier methods, or abstinence) with their partner during the trial and for at least 6 months after the last dose. Individuals of reproductive age had to have a negative blood pregnancy test within 7 days before enrollment; 10. Fully understand the clinical trial and voluntarily provide written informed consent.
Exclusion criteria
Exclusion criteria: 1. Prior anti-HER2 therapy; 2. Known symptomatic central nervous system or leptomeningeal metastases or other evidence of uncontrolled central nervous system or leptomeningeal metastases in individuals who were judged by the investigator to be ineligible for enrollment; 3. Patients who are receiving long-term immunosuppressive therapy (e.g., cyclosporine) or who require daily systemic steroid therapy (e.g., >20 mg of prednisone or its equivalent), except those treated with topical glucocorticoids by nasal spray, inhalation, or other route; 4. The adverse reactions of previous antineoplastic therapy have not recovered to CTCAE 5.0 grade =1 (except for toxicities without safety risks judged by investigators such as alopecia); 5. Clinically significant gastrointestinal disease, including but not limited to severe liver disease, malabsorption syndrome, ulcerative colitis, inflammatory bowel disease; 6. Peripheral neuropathy of grade 3 or above; 7. Known low level or deficiency of dihydropyrimidine dehydrogenase (DPD); 8. Individuals who underwent major surgery or invasive treatment (excluding needle biopsy, central venous catheter chemotherapy, access ports, stent implantation, biliary drainage, and cholecystostomy) within 28 days before the first dose; 9. Concurrent participation in another clinical trial; 10. Use of any Chinese herbal medicine or patent Chinese medicine with anti-cancer activity approved by the National Medical Products Administration within 14 days before the first dose (regardless of the type of cancer); 11. Known severe allergic reactions to the study drug or other ingredients or excipients in the preparation; 12. Active bacterial, fungal, or viral infection within 14 days before the first dose (defined as requiring intravenous antibacterial, antifungal, or antiviral treatment). Individuals who had no clinical manifestations of active infection before the first dose and were given infection prophylaxis could be considered for enrollment. 13. Uncontrolled serous effusion requiring frequent drainage or medical intervention (e.g., pleural effusion, peritoneal effusion, pericardial effusion, etc.) within 7 days before the first dose, requiring additional intervention (excluding exfoliative cytology of exudate) within 2 weeks after the intervention; 14. Have an autoimmune disease, These include, but are not limited to, Crohn's disease, ulcerative colitis, systemic lupus erythematosus, sarcoidosis, and Wegener "Syndromes (polyangiitis granulomatosis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis), autoimmune hepatitis, systemic sclerosis (scleroderma, etc.), Hashimoto's thyroiditis (exceptions see below), autoimmune vasculitis, autoimmune neuropathy (Guillain-Barre syndrome), etc." Exceptions were type I diabetes, hypothyroidism that was stable with hormone-replacement therapy (including that due to autoimmune thyroid disease), psoriasis or vitiligo that did not require systemic therapy, and hypothyroidism that was stable with hormone-replacement therapy. 15. HBsAg positive and HBV-DNA higher than measurable lower limit or 1000 copies /mL (500 IU/mL) (whichever is lower), HCV antibody positive and HCV-RNA higher than measurable lower limit or 1000 copies /mL (whichever is lower); HIV antibody test was positive. 16. History of noninfectious interstitial lung disease, or interstitial pneumonia requiring steroid therapy; 17. A history of severe cardiovascular disease, including but not limited to: (1) Severe card
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| 3-year disease free survival rate;Objective response rate,ORR;R0 resection rate;Tumor regression grade;Frequency and severity of adverse events (AE);Vital signs;Physical Examination;Electrocardiogram;Changes in safety laboratory indicators;Surgical Complications;Mortality at 30 and 90 days after surgery;Length of Stay;Reoperation rate; | — |
Countries
China
Contacts
Public ContactXicheng Wang
Peking Union Medical College Hospital
Outcome results
None listed