A Phase Ⅱ/Ⅲ Clinical Trial of RC148 Plus Chemotherapy as 1L Therapy for Unresectable or Metastatic Colorectal Cancer

Официальное название

A Randomized, Multicenter, Phase Ⅱ/Ⅲ Study of RC148 Combined With Chemotherapy Versus Bevacizumab Combined With Chemotherapy as First-line Treatment for Unresectable or Metastatic Colorectal Cancer

Обзор

This is a Phase Ⅱ/Ⅲ study. The purpose of this study is to evaluate the efficacy and safety of RC148 combined with chemotherapy for the first-line treatment of unresectable metastatic colorectal cancer (CRC)

Подробное описание

Primary objective in Phase II: To preliminarily evaluate the efficacy of RC148 combined with chemotherapy as first - line treatment for unresectable or metastatic CRC.

Primary objective in Phase III: To evaluate the efficacy of RC148 combined with chemotherapy compared with bevacizumab combined with chemotherapy as first - line treatment for unresectable or metastatic CRC.

Вмешательства

• Препарат RC148 (Dose 1) plus Capecitabine and Oxaliplatin
  RC148 (Dose 1) plus Capecitabine and Oxaliplatin
• Препарат RC148 (Dose 2) plus Capecitabine and Oxaliplatin
  RC148 (Dose 2) plus Capecitabine and Oxaliplatin

Первичные конечные точки

• Objective Response Rate (ORR) [Срок оценки: 24 months]

Вторичные конечные точки (5)

• Duration of Response (DoR) [Срок оценки: 24 months]
• Disease Control Rate (DCR) [Срок оценки: 24 months]
• Time to Response (TTR) [Срок оценки: 24 months]
• Overall Survival (OS) [Срок оценки: 36 months]
• AEs/SAE [Срок оценки: 36 months]

Критерии участия

Критерии включения

• Voluntarily agree to participate in the study, sign the informed consent form, and be able to comply with the study protocol.
• Aged 18-75 years old (including 18 years old and 75 years old).
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
• Expected survival period ≥ 12 weeks.
• At least one measurable lesion according to RECIST v1.1 criteria.
• Histologically or cytologically confirmed colorectal adenocarcinoma, judged by the investigator as unsuitable for curative treatment, and no prior systemic anti-tumor treatment in the recurrent or metastatic stage.
• Subjects must be able to provide tumor tissue samples for biomarker detection.
• Adequate bone marrow, liver, kidney, and coagulation function.
• Female subjects of childbearing potential must agree to use at least one medically approved contraceptive method during the study treatment and for 6 months after the end of the study treatment, and must have a negative blood pregnancy test within 7 days before study enrollment; male subjects must agree to use at least one medically approved contraceptive method during the study treatment and for 6 months after the end of the study treatment.

Критерии исключения

• Known to have microsatellite instability-high (MSI-H) or deficient mismatch repair (dMMR).
• Imaging shows obvious tumor necrosis or cavitation, and the investigator judges that participation in the study may increase the risk of bleeding.
• Subjects with brain metastases.
• Toxicities from prior anti-tumor therapy have not recovered to ≤ grade 1 according to NCI-CTCAE v6.0.
• Known hypersensitivity or delayed-type allergy to any component of the study drug or similar drugs.
• Subjects with refractory nausea and vomiting, chronic gastrointestinal diseases, or other diseases that may interfere the adequate absorption, distribution, metabolism, or excretion of oral drugs.
• Subjects with acute, chronic, or symptomatic infections.
• Subjects with diagnosed or suspected interstitial lung disease (ILD), drug-related pneumonia, radiation pneumonitis, severe impairment of lung function, or other lung diseases.
• Subjects with active inflammatory bowel disease, a history of gastrointestinal perforation and/or fistula, or clinical symptoms of gastrointestinal obstruction.
• Subjects with severe arterial/venous thromboembolic events within 6 months before randomization.
• Active gastrointestinal bleeding, hemoptysis, peptic ulcer, or hemorrhagic events requiring intervention within 28 days before randomization; or presence of severe esophagogastric varices or epistaxis.
• Presence of symptomatic or intervention-requiring third-space effusions.
• Subjects with active or previously diagnosed autoimmune diseases that may recur.
• History of other invasive malignant tumors within 5 years before randomization, or presence of any residual evidence of previously diagnosed malignant tumors.
• Subjects who are pregnant, lactating, or planning to become pregnant.

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 · 19 центров

• Beijing Cancer Hospital — Пекин
• Beijing Friendship Hospital, Capital Medical University — Пекин
• Chongqing University Cancer Hospital — Чунцин
• Fujian Medical University Union Hospital — Фучжоу
• Meizhou People's Hospital — Meizhou
• Guangxi Medical University Cancer Hospital — Нанкин
• The Fourth Hospital of Hebei Medical University and Hebei Tumor Hospital — Shijiazhuang
• The First Affiliated Hospital of Zhengzhou University — Чжэнчжоу
• … и ещё 11 центров

Идентификаторы

NCT: NCT07462143 · RC148-C303

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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