NCT06063018 RC48 Combined With Tislelizumab for Second-line Treatment of HER2 Expression in Recurrent Cervical Cancer
| NCT ID | NCT06063018 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Peking Union Medical College Hospital |
| Condition | Cervical Cancer Recurrent |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2023-08-16 |
| Primary Completion | 2025-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 30 participants in total. It began in 2023-08-16 with a primary completion date of 2025-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
There is currently no standardized treatment for patients who have undergone first-line standard treatment. In this study, We investigated the efficacy and safty of RC48 combined with Tislelizumab in the second-line treatment of patients with HER2 expression in recurrent cervical cancer.
Eligibility Criteria
Inclusion Criteria: 1. Female subjects aged from 18 to 75 years old； 2. Have Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0 or 1； 3. Have a life expectancy of at least 6 months, in the opinion of the investigator； 4. Histologically or cytologically confirmed primary cervical squamous cell carcinoma, adenocarcinoma, adenosquamous cell carcinoma, or small cell (neuroendocrine) cervical cancer; 5. Have measurable disease assessable by RECIST v1.1； 6. Adequate haematological, hepatic and renal functions defined by the protocol； Pathologically diagnosed patients with HER2 expression （defined as: IHC 3+ or IHC 2+ or HC 1+）advanced cervical cancer ；Note：It is also acceptable if the subject has previous test results (confirmed by the investigator)； 7. Negative blood pregnancy test at Screening for women of childbearing potential；Highly effective contraception for female subjects if the risk of conception exists； Exclusion Criteria: 1. History of malignant tumors other than cervical cancer, except for the following two cases：a. The patient had received a potentially curative treatment and had no evidence of the disease for 5 years；b. Successful resection of skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder carcinoma, cervical carcinoma in situ, and other carcinoma in situ was received； 2. Previous malignant disease (other than cervical cancer) within the last 5 years with the exception of basal or squamous cell carcinoma of the skin or carcinoma in situ (bladder, cervical, colorectal, breast)Previous stem cell allogeneic or parenchymal organ transplants； 3. Patients who had previously received other anti-tumor systemic therapy (including traditional Chinese medicine with anti-tumor indications) less than 4 weeks before the use of this study, or adverse events caused by previous treatment did not recover to ≤CTCAE grade 1 (except for alopecia and pigmentation)； 4. Had received a live vaccine within 4 weeks prior to the start of study dosing or planned to receive any vaccine (except for COVID-19 vaccine) during the study period； 5. Previous or current congenital or acquired immunodeficiency disease； 6. Previous treatment with other antibody-coupled drugs； 7. Has not recovered from surgery, such as the presence of unhealed incisions or serious postoperative complications； 8. The patient had a known or suspected allergy to the experimental drug； 9. The New York College of Cardiology (NYHA) classiifies heart failure as grade 3 and above； 10. Severe infections that are active or poorly controlled clinically; Active infections, including: a. HIV (HIV1/2 antibody) positive; b. Active hepatitis B (HBsAg positive or HBV DNA \> 2000IU/ml and abnormal liver function); c. Active hepatitis C (HCV antibody positive or ≥103 copies /ml of HCV RNA and abnormal liver function); d. active tuberculosis; d. Other uncontrolled active infections (CTCAE V5.0 \> Grade 2); 11. Other significant clinical and laboratory abnormalities considered to affect safety assessment, such as uncontrolled diabetes, chronic kidney disease, grade II or above peripheral neuropathy (CTCAE V5.0), thyroid dysfunction, etc.； Other conditions deemed unsuitable for inclusion by the researchers；
Contact & Investigator
Lei Li, PhD
PRINCIPAL INVESTIGATOR
Peking Union Medical College Hospital
Frequently Asked Questions
Who can join the NCT06063018 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 75 Years, studying Cervical Cancer Recurrent. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06063018 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06063018 currently recruiting?
Yes, NCT06063018 is actively recruiting participants. Contact the research team at lileigh@163.com for enrollment information.
Where is the NCT06063018 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06063018 clinical trial?
NCT06063018 is sponsored by Peking Union Medical College Hospital. The principal investigator is Lei Li, PhD at Peking Union Medical College Hospital. The trial plans to enroll 30 participants.
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