Recurrent Cervical Cancer, Metastatic Cervical Cancer
Conditions
Brief summary
The main objective of this study is to evaluate the efficacy of SHR-A2102 versus investigator's choice of chemotherapy in patients with platinum-based chemotherapy and PD-(L)1 inhibitor treatment failed recurrent or metastatic cervical cancer.
Interventions
Topotecan Hydrochloride for injection.
Paclitaxel for injection (Albumin bound).
SHR-A2102 for injection.
Pemetrexed Disodium for injection.
DRUGGemcitabine Hydrochloride for Injection
Gemcitabine Hydrochloride for injection.
Sponsors
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
An open-label, randomized, controlled, multicenter, phase III Study.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Participate in the study voluntarily, sign the informed consent form. 2. Histologically or cytologically confirmed cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma that is deemed unsuitable for radical surgery and/or radical radiotherapy or chemoradiotherapy. 3. Provide primary or metastatic tumor samples. 4. At least one measurable lesion (RECIST version 1.1). 5. ECOG 0\~ 1. 6. With adequate organ functions. 7. Expected overall survival is ≥12 weeks.
Exclusion criteria
1. With known untreated or active central nervous system (CNS) tumor metastasis, or a history of or current leptomeningeal metastasis. 2. With symptomatic, poorly controlled, or moderate-to-severe pleural effusion, pericardial effusion, or ascites. 3. With a history of or concurrent other malignant tumor(s). 4. Participants with gastrointestinal perforation or fistula, urogenital fistula, or those at risk of fistula within 3 months prior to randomization. 5. With known or suspected interstitial lung disease. 6. With intestinal obstruction or signs/symptoms suggestive of intestinal obstruction within 3 months prior to randomization. 7. With poorly controlled cardiac clinical symptoms or diseases. 8. Experienced arterial/venous thromboembolic events within 3 months prior to randomization. 9. With severe infections occurring within 1 month prior to randomization. 10. With active hepatitis B (defined as positive hepatitis B surface antigen \[HBsAg\] test and hepatitis B virus \[HBV\] DNA ≥500 IU/mL at screening) or active hepatitis C (defined as positive hepatitis C virus antibody \[HCV-Ab\] test and detectable hepatitis C virus \[HCV\] RNA at screening). 11. With active tuberculosis infection within 1 year prior to randomization, or a history of active tuberculosis infection more than 1 year ago without proper treatment. 12. With a history of immunodeficiency, including a positive human immunodeficiency virus (HIV) test, other acquired or congenital immunodeficiency diseases, or a history of organ transplantation. 13. Have received systemic anti-tumor therapy within 28 days prior to randomization. 14. With uncontrolled psychiatric disorders, or known history of alcoholism, drug abuse, or substance dependence, incarceration, or other conditions that may affect the completion of study procedures. 15. Any other condition that, in the judgment of the investigator, may increase the risk associated with study participation, interfere with the interpretation of study results, or make the participant unsuitable for the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival (OS) | Up to 3 years. | OS is the time interval from the start of treatment to death due to any reason or lost of follow-up. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression free survival (PFS) | Up to 3 years. | Assessed by the investigator according to RECIST 1.1 criteria. |
| Objective Response Rate (ORR) | Up to 3 years. | Assessed by the investigator according to RECIST 1.1 criteria. |
| Duration of response (DoR) | Up to 3 years. | Assessed by the investigator according to RECIST 1.1 criteria. |
| Disease control rate (DCR) | Up to 3 years. | Assessed by the investigator according to RECIST 1.1 criteria. |
| Adverse Events (AEs) | Up to 3 years. | Including incidence and grade, judged according to NCI-CTCAE V5.0 standards. |
| Serious Adverse Events (AEs) | Up to 3 years. | Including incidence and grade, judged according to NCI-CTCAE V5.0 standards. |
| Plasma concentrations of SHR-A2102 | Up to 3 years. | Pharmacokinetics (PK) traits of SHR-A2102. |
| Plasma concentrations of SHR-A2102 metabolites | Up to 3 years. | Pharmacokinetics (PK) traits of SHR-A2102. |
| Incidence of Anti-Drug Antibody (ADA) of SHR-A2102 | Up to 3 years. | — |
| Incidence of Neutralizing Antibodies (Nab) of SHR-A2102 | Up to 3 years. | — |
Countries
China
Contacts
CONTACTZhifei Lin
Outcome results
None listed