A Study 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

Официальное название

An Open-label, Randomized, Controlled, Multicenter, Phase III Study 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

Обзор

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.

Вмешательства

• Препарат SHR-A2102 for Injection
  SHR-A2102 for injection.
• Препарат Pemetrexed Disodium for Injection
  Pemetrexed Disodium for injection.
• Препарат Gemcitabine Hydrochloride for Injection
  Gemcitabine Hydrochloride for injection.
• Препарат Topotecan Hydrochloride for Injection
  Topotecan Hydrochloride for injection.
• Препарат Paclitaxel for Injection (Albumin bound)
  Paclitaxel for injection (Albumin bound).

Первичные конечные точки

• Overall survival (OS) [Срок оценки: Up to 3 years.]

Вторичные конечные точки (10)

• Progression free survival (PFS) [Срок оценки: Up to 3 years.]
• Objective Response Rate (ORR) [Срок оценки: Up to 3 years.]
• Duration of response (DoR) [Срок оценки: Up to 3 years.]
• Disease control rate (DCR) [Срок оценки: Up to 3 years.]
• Adverse Events (AEs) [Срок оценки: Up to 3 years.]
• Serious Adverse Events (AEs) [Срок оценки: Up to 3 years.]
• Plasma concentrations of SHR-A2102 [Срок оценки: Up to 3 years.]
• Plasma concentrations of SHR-A2102 metabolites [Срок оценки: Up to 3 years.]
• Incidence of Anti-Drug Antibody (ADA) of SHR-A2102 [Срок оценки: Up to 3 years.]
• Incidence of Neutralizing Antibodies (Nab) of SHR-A2102 [Срок оценки: Up to 3 years.]

Критерии участия

Критерии включения

• Participate in the study voluntarily, sign the informed consent form.
• 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.
• Provide primary or metastatic tumor samples.
• At least one measurable lesion (RECIST version 1.1).
• ECOG 0\~ 1.
• With adequate organ functions.
• Expected overall survival is ≥12 weeks.

Критерии исключения

• With known untreated or active central nervous system (CNS) tumor metastasis, or a history of or current leptomeningeal metastasis.
• With symptomatic, poorly controlled, or moderate-to-severe pleural effusion, pericardial effusion, or ascites.
• With a history of or concurrent other malignant tumor(s).
• Participants with gastrointestinal perforation or fistula, urogenital fistula, or those at risk of fistula within 3 months prior to randomization.
• With known or suspected interstitial lung disease.
• With intestinal obstruction or signs/symptoms suggestive of intestinal obstruction within 3 months prior to randomization.
• With poorly controlled cardiac clinical symptoms or diseases.
• Experienced arterial/venous thromboembolic events within 3 months prior to randomization.
• With severe infections occurring within 1 month prior to randomization.
• 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).
• 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.
• 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.
• Have received systemic anti-tumor therapy within 28 days prior to randomization.
• 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.
• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Sun Yat-sen University Cancer Center — Гуанчжоу

Идентификаторы

NCT: NCT07418749 · SHR-A2102-310

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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