Efficacy and Safety of Trastuzumab Biosimilars and Pertuzumab Biosimilars Combined With Chemotherapy for Neoadjuvant Treatment of Patients With Locally Advanced HER2-positive Rectal Cancer

NCT07108127 | Recruiting Phase 2

• 2 other identifiers: K77202024-PUMCH-E-013
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Rectal Cancer; HER2-positive

Outcome Measures

Primary Outcomes (1)

• CR

  Complete remission (CR) including pCR and cCR

  through study completion, an average of 1 year

Secondary Outcomes (4)

• ORR

  through study completion, an average of 1 year

• DFS

  through study completion, an average of 1 year

• R0 resection rate

  through study completion, an average of 1 year

• TRG

  through study completion, an average of 1 year

Study Arms (1)

treatment arm

EXPERIMENTAL

Trastuzumab biosimilars and pertuzumab biosimilars in combination with oxaliplatin and capecitabine

Drug: Trastuzumab biosimilars and pertuzumab biosimilars plus XELOX

Interventions

Trastuzumab biosimilars and pertuzumab biosimilars plus XELOX DRUG

Trastuzumab biosimilars and pertuzumab biosimilars combined with oxaliplatin and capecitabine

treatment arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years old;
• Patients with rectal cancer confirmed by histology or cytology; locally advanced (cT3/T4, N+, distance from the lower edge of the tumor to the anal verge ≤ 12 cm) rectal adenocarcinoma (using the 8th edition of the AJCC TNM staging);
• HER2 positive after detection: HER2 positive is defined as IHC test result 3+, or IHC test result 2+ and FISH method confirms positive HER2 gene amplification;
• Tumor tissue gene test RAS/BRAF is wild type (previous test results are acceptable);
• Previous treatment meets the following requirements: no previous anti-tumor treatment;
• ECOG PS score 0-1;
• Expected survival period of at least 3 months;
• Adequate organ function, laboratory tests meet the following criteria (no blood transfusion or hematopoietic stimulating factor treatment within 14 days):
• Absolute neutrophil count (ANC) ≥ 1.5×109/L
• Hemoglobin (Hb) ≥ 90g/L
• Platelets ≥ 100×109/L
• Albumin ≥ 30g/L
• Serum creatinine ≤ 1.5×ULN and creatinine clearance \> 50 mL/min (calculated according to Cockcroft-Gault formula)
• Total bilirubin ≤ 1.5×ULN;
• Alanine aminotransferase, aspartate aminotransferase ≤ 2.5×ULN, alanine aminotransferase, aspartate aminotransferase ≤ 5×ULN for patients with liver metastasis;

You may not qualify if:

• Patients who have received anti-HER2 drug treatment in the past;
• Patients who are receiving long-term immunosuppressive therapy (such as cyclosporine) or require daily systemic steroid therapy (such as \>20 mg prednisone or equivalent drugs), except those who use local glucocorticoids by nasal spray, inhalation or other routes;
• The adverse reactions of previous anti-tumor treatment have not recovered to CTCAE 5.0 grade evaluation ≤1 (except for toxicities such as alopecia that the investigator judges to have no safety risks);
• Clinically significant gastrointestinal diseases, including but not limited to severe liver disease, malabsorption syndrome, ulcerative colitis, inflammatory bowel disease;
• Peripheral neuropathy of grade 3 or above;
• Known low level or deficiency of dihydropyrimidine dehydrogenase (DPD);
• Individuals who have undergone major surgery or invasive intervention within 28 days before the first dose (excluding puncture biopsy, central venous catheter chemotherapy, infusion port, stent implantation and bile duct drainage for relieving biliary obstruction, and cholecystostomy surgery);
• Participating in another clinical trial at the same time;
• Using any Chinese herbal medicine or Chinese patent medicine with anti-cancer activity approved by the State Food and Drug Administration within 14 days before the first dose (regardless of the type of cancer);
• Known to have severe allergic reactions to the study drug or other ingredients or excipients in the preparation;
• Within 7 days before the first dose, there is uncontrolled serous effusion that requires frequent drainage or medical intervention (such as pleural effusion, peritoneal effusion, pericardial effusion, etc., which requires additional intervention within 2 weeks after intervention, excluding exfoliative cytology testing of exudate);
• Suffering from autoimmune diseases, including but not limited to Crohn's disease, ulcerative colitis, systemic lupus erythematosus, sarcoidosis, Wegener syndrome (granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis), autoimmune hepatitis, systemic sclerosis (scleroderma, etc.), Hashimoto's thyroiditis (exceptions are shown below), autoimmune vasculitis, autoimmune neuropathy (Guillain-Barre syndrome), etc. The following conditions are excluded: type 1 diabetes, hypothyroidism that is stable with hormone replacement therapy (including hypothyroidism caused by autoimmune thyroid disease), psoriasis or vitiligo that does not require systemic treatment;
• HBsAg positive and HBV-DNA higher than the measurable lower limit or 1000 copies/mL (500 IU/mL) (whichever is lower), HCV antibody positive and HCV-RNA higher than the measurable lower limit or 1000 copies/mL (whichever is lower); HIV antibody test positive;
• History of non-infectious interstitial lung disease, or interstitial pneumonia requiring hormone treatment;
• History of severe cardiovascular disease, including but not limited to:

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking union medical college hospital

Beijing, 100032, China

RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

XELOX

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Central Study Contacts

Xicheng Wang Prof. Wang, Dr.med

CONTACT

010-69158370; xicheng_wang@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Trastuzumab biosimilars and pertuzumab biosimilars in combination with oxaliplatin and capecitabine

Study Record Dates

• First Submitted: March 25, 2025
• First Posted: August 6, 2025
• Study Start: June 20, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 6, 2025

Record last verified: 2025-03

Locations

CN (1)