Actively Recruiting
Efficacy and Safety of Trastuzumab Biosimilars and Pertuzumab Biosimilars Combined With Chemotherapy for Neoadjuvant Treatment of Patients With Locally Advanced HER2-positive Rectal Cancer
Led by Peking Union Medical College Hospital · Updated on 2025-08-06
24
Participants Needed
1
Research Sites
79 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study was to evaluate the complete response rate (CR) of trastuzumab biosimilars and pertuzumab biosimilars combined with oxaliplatin and capecitabine in neoadjuvant treatment of patients with locally advanced (cT3/T4, N+, distance from the lower edge of the tumor to the anal verge ≤12 cm) HER2-positive rectal adenocarcinoma.
CONDITIONS
Official Title
Efficacy and Safety of Trastuzumab Biosimilars and Pertuzumab Biosimilars Combined With Chemotherapy for Neoadjuvant Treatment of Patients With Locally Advanced HER2-positive Rectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Histologically or cytologically confirmed rectal cancer
- Locally advanced rectal adenocarcinoma (cT3/T4, N+, tumor 64 12 cm from anal verge)
- HER2 positive defined by IHC 3+ or IHC 2+ with FISH confirmation
- Tumor tissue gene test showing RAS/BRAF wild type
- No previous anti-tumor treatment
- ECOG performance status of 0 or 1
- Expected survival of at least 3 months
- Adequate organ function with specified blood and liver test values
- Agreement to use reliable contraception during the trial and for 6 months after last dose
- Female participants of childbearing potential must have a negative pregnancy test within 7 days before enrollment
- Informed consent voluntarily signed
You will not qualify if you...
- Prior treatment with anti-HER2 drugs
- Uncontrolled central nervous system or meningeal metastasis
- Long-term immunosuppressive therapy or daily systemic steroids above specified doses
- Unresolved adverse reactions from prior anti-tumor treatments above grade 1 (except alopecia without safety risk)
- Severe gastrointestinal diseases including liver disease and inflammatory bowel disease
- Peripheral neuropathy grade 3 or higher
- Known dihydropyrimidine dehydrogenase (DPD) deficiency
- Major surgery or invasive procedures within 28 days before first dose (with specified exceptions)
- Concurrent participation in other clinical trials
- Use of Chinese herbal or patent medicines with anti-cancer activity within 14 days before first dose
- Known severe allergic reactions to study drugs or ingredients
- Active infections requiring intravenous antimicrobial treatment within 14 days before first dose
- Uncontrolled serous effusion requiring frequent drainage within 7 days before first dose
- Autoimmune diseases except specified stable conditions
- Positive for certain viral infections with viral load above limits or positive HIV test
- History of non-infectious interstitial lung disease requiring hormone treatment
- Severe cardiovascular diseases including specific arrhythmias, heart failure, recent major cardiac events, or poorly controlled hypertension
- History of other malignant tumors within 5 years except certain localized tumors
- Live vaccine within 28 days before randomization (with influenza vaccine exception)
- Known mismatch repair deficiency or high microsatellite instability
- Psychiatric disorders affecting compliance
- Pregnant or breastfeeding women
- Use of strong CYP3A4 or UGT1A1 inhibitors within 2 weeks before first dose
- Any condition judged by investigator to prevent safe participation or study compliance
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Peking union medical college hospital
Beijing, China, 100032
Actively Recruiting
Research Team
X
Xicheng Wang Prof. Wang, Dr.med
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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