Rectal CancerPhase 2NePHeraNCT07108127
Efficacy and Safety of Trastuzumab Biosimilars and Pertuzumab Biosimilars Combined With Chemotherapy for Neoadjuvant Treatment of Patients With Locally Advanced HER2-positive Rectal Cancer
A Phase 2 study testing Trastuzumab biosimilars and pertuzumab biosimilars plus XELOX in people with Rectal Cancer and HER2-positive, run by Peking Union Medical College Hospital at 1 site in China.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer, HER2-positive
- What is being tested?
- Trastuzumab biosimilars and pertuzumab biosimilars plus XELOX
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 20 Jun 2025to 31 Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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;
- Activated partial thromboplastin time ≤ 1.5×ULN; international normalized ratio ≤ 1.5×ULN.
- Eligible individuals (male and female) of childbearing potential must agree to use reliable contraceptive methods (hormonal contraceptives, barrier methods or abstinence) with their partners during the trial and for at least 6 months after the last dose. Female individuals of childbearing age must have a negative blood pregnancy test within 7 days before enrollment;
- Fully understand this clinical trial and voluntarily sign a written informed consent.
Who cannot join
- Patients who have received anti-HER2 drug treatment in the past;
- Patients with known clinical symptoms of central nervous system metastasis or meningeal metastasis, or other evidence that individual central nervous system metastasis or meningeal metastasis has not been controlled, and are judged by the investigator to be unsuitable for inclusion;
- 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;
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- 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;
- Active bacterial, fungal or viral infection within 14 days before the first dose (defined as requiring intravenous antibacterial, antifungal or antiviral drug treatment). Individuals who have no clinical manifestations of active infection before the first dose and are given preventive treatment for infection may be considered for inclusion in the group;
- 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:
- Severe cardiac rhythm or conduction abnormalities, such as ventricular arrhythmias requiring clinical intervention, II-III degree atrioventricular block, etc.;
- QTcF > 450 milliseconds at rest (if the first 12-lead electrocardiogram QTcF > 450 milliseconds, can be repeated twice, take the average of 3 times);
- Acute coronary syndrome, congestive heart failure, heart or other vascular stent implantation, angioplasty or cardiac surgery, stroke or other cardiovascular events of grade 3 or above within 6 months before the first administration;
- New York Heart Association heart function grade ≥ II or left ventricular ejection fraction <50%;
- Any factors that increase the risk of QTc prolongation or arrhythmia, such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death of first-degree relatives under 40 years old, use of any concomitant drugs known to prolong the QT interval;
- Poorly controlled hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg during the screening period). 18) History of other malignant tumors within 5 years or other active malignant tumors at the same time (cured localized tumors, such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, prostate carcinoma in situ, cervical carcinoma in situ, breast carcinoma in situ, etc. can be included);
- 19) Vaccinated with live vaccine within 28 days before randomization. Note: Seasonal influenza vaccine is an inactivated vaccine in a broad sense and is allowed to be used; intranasal influenza vaccine is a live vaccine and is not allowed to be used (applicable to immunotherapy); 20) Known mismatch repair protein deficiency (dMMR) or microsatellite high instability (MSI-H) 21) Current psychiatric disorders that affect compliance; 22) Pregnant or lactating women; 23) Patients who have used strong CYP3A4 inhibitors or strong inducers, or strong UGT1A1 inhibitors within 2 weeks before the first dose (applicable to FOLFIRI regimen treatment); 24) The investigator believes that the patient is not suitable for participating in this clinical trial for other reasons, including but not limited to: patients with concurrent serious or uncontrollable medical conditions, safety risks, interference with the interpretation of research results, and impact on trial compliance, etc.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking union medical college hospital
Beijing, 100032
Lian Dr. Liu, Dr.med, 010-69158370, liulian@pumch.cn
About this study
Official title: Phase II Clinical Study on the Efficacy and Safety of Trastuzumab Biosimilars and Pertuzumab Biosimilars Combined With Chemotherapy for Neoadjuvant Treatment of Patients With Locally Advanced HER2-positive Rectal Cancer
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
- Being tested
- Trastuzumab biosimilars and pertuzumab biosimilars plus XELOX
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trastuzumab biosimilars and pertuzumab biosimilars plus XELOXDrug
Trastuzumab biosimilars and pertuzumab biosimilars combined with oxaliplatin and capecitabine
| Study group | Role | What they receive |
|---|---|---|
| treatment arm | Experimental | Trastuzumab biosimilars and pertuzumab biosimilars in combination with oxaliplatin and capecitabine Receives: Drug: Trastuzumab biosimilars and pertuzumab biosimilars plus XELOX |
What is being measured
The primary outcome is the main question the study is designed to answer.
CR
Complete remission (CR) including pCR and cCR
Measured: through study completion, an average of 1 year
Secondary outcomes (4)
ORR
overall response rate
Measured: through study completion, an average of 1 year
DFS
disease free survival
Measured: through study completion, an average of 1 year
R0 resection rate
R0 resection rate
Measured: through study completion, an average of 1 year
TRG
tumor regression grade
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2025
- Study start20 Jun 2025
- Primary completion1 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Trastuzumab biosimilars and pertuzumab biosimilars in combination with oxaliplatin and capecitabine
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07108127
- Sponsor's protocol ID
- K7720
- Other IDs
- 2024-PUMCH-E-013
- Acronym
- NePHera
- Status last verified
- Mar 2025
- First submitted
- 25 Mar 2025
- Last updated
- 6 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Clinical Study on the Efficacy and Safety of Trastuzumab Biosimilars and Pertuzumab Biosimilars Combined With Chemotherapy for Neoadjuvant Treatment of Patients With Locally Advanced HER2-positive Rectal Cancer
- ClinicalTrials.gov ID
- NCT07108127
- Acronym / sponsor ID
- NePHera / K7720
- Conditions
- Rectal Cancer, HER2-positive
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 20 Jun 2025 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 6 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Trastuzumab biosimilars and pertuzumab biosimilars in combination with oxaliplatin and capecitabine
| Arm | Type | Receives |
|---|---|---|
| treatment arm | Experimental | Drug: Trastuzumab biosimilars and pertuzumab biosimilars plus XELOXTrastuzumab biosimilars and pertuzumab biosimilars in combination with oxaliplatin and capecitabine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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;
Key exclusion criteria (24 listed)
- Patients who have received anti-HER2 drug treatment in the past;
- Patients with known clinical symptoms of central nervous system metastasis or meningeal metastasis, or other evidence that individual central nervous system metastasis or meningeal metastasis has not been controlled, and are judged by the investigator to be unsuitable for inclusion;
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trastuzumab biosimilars and pertuzumab biosimilars plus XELOXTrastuzumab biosimilars and pertuzumab biosimilars combined with oxaliplatin and capecitabine | Drug | treatment arm |
Primary outcome
CR
Time frame: through study completion, an average of 1 year
Complete remission (CR) including pCR and cCR
4 secondary outcomes
ORR
Time frame: through study completion, an average of 1 year
DFS
Time frame: through study completion, an average of 1 year
R0 resection rate
Time frame: through study completion, an average of 1 year
TRG
Time frame: through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Trastuzumab biosimilars and pertuzumab biosimilars plus XELOX in people with Rectal Cancer and HER2-positive, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xicheng Wang Prof. Wang, Dr.med (010-69158370, xicheng_wang@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CR (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2025.