RC48 Combined With Tislelizumab for Second-line Treatment of HER2 Expression in Recurrent Cervical Cancer
Recruiting
Phase 2Interventional Study
Cervical Cancer Recurrent
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 75
Sex
Female
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
30 (estimated)
Sponsor
Peking Union Medical College Hospital · Other
Who this trial is looking for
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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.
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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 squa…
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;
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