A Clinical Study of Adebrelimab in Combination With SHR-8068 and Chemoradiotherapy as Perioperative Therapy for Locally Advanced Rectal Cancer

Официальное название

A Randomized, Double-blind, Placebo-controlled, Multicenter Phase II/III Clinical Study of Adebrelimab Combined With SHR-8068 and Chemoradiotherapy as Perioperative Therapy for Locally Advanced Resectable Rectal Cancer

Обзор

The study is being conducted to evaluate the safety and efficacy of Adebrelimab and SHR-8068 in combination with chemoradiotherapy in subjects with rectal cancer.

Вмешательства

• Препарат Adebrelimab in combination with SHR-8068 and chemotherapy
  Adebrelimab in combination with SHR-8068 and chemotherapy.
• Препарат Adebrelimab combined with chemotherapy
  Adebrelimab combined with chemotherapy.
• Препарат Chemotherapy
  Chemotherapy.

Первичные конечные точки

• Phase II: pCR (Pathological Complete Response) rate [Срок оценки: 12 months]

Вторичные конечные точки (8)

• Phase II: Clinical complete response (cCR) rate [Срок оценки: 60 months]
• Phase II: Disease-free survival (DFS) [Срок оценки: 60 months]
• Phase II: EFS (Event Free Survival) [Срок оценки: 60 months]
• Phase II: Tumor regression grade (TRG) [Срок оценки: 60 months]
• Phase II: R0 resection rate [Срок оценки: 60 months]
• Phase II: length of hospital stay [Срок оценки: 60 months]
• Phase II: Overall survival (OS) [Срок оценки: 60 months]
• Phase II: Perioperative mortality (within 30 days and 90 days after surgery) [Срок оценки: 60 months]

Критерии участия

Критерии включения

• Subjects must voluntarily agree to participate in the trial and sign a written informed consent form.
• Male or female ≥ 18 years old and ≤75 years old.
• ECOG performance status of 0-1.
• An assessment of resectable locally advanced rectal.
• Has not received any anti-tumor treatment for rectal cancer.
• With a life expectancy of ≥2 years.
• Male participants whose partners are fertile women and fertile female participants must take effective contraceptive measures together with their partners from the time of signing the informed consent form until 6 months after the last administration of the investigational drug or the last radiotherapy. Female participants with fertility must have a negative serum or urine test for human chorionic gonadotropin (HCG) within 7 days before the first administration of the drug (if the serum HCG test is positive, pregnancy should be ruled out and further discussion with the sponsor should be conducted), and they must be not in the lactation period.

Критерии исключения

• Patients with rectal cancer who have experienced local recurrence after previous treatment.
• Patients with concurrent colon tumors.
• Patients with initially unresectable colorectal cancer as evaluated by researchers or those whose condition is determined by researchers to be intolerant to surgery.
• Clinical or imaging examinations suggest the presence of intestinal obstruction or perforation, or those assessed by researchers as having a relatively high risk of perforation or bleeding.
• With distant metastases.
• Imaging examination of rectal cancer indicated positive lateral lymph nodes.
• Having received surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc. for tumors.
• Female participants who are pregnant, breastfeeding or planning to become pregnant during the study period.
• There are uncontrollable mental illnesses and other circumstances known to affect the completion of the research procedures, such as alcohol abuse, drug abuse or drug abuse, and criminal detention.
• Any other factors that may increase the risk of participating in the study, interfere with the study results, or make participation in the study inappropriate as judged by investigators.

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 · 2 центра

• Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Te — Ухань
• Zhejiang Cancer Hospital — Ханчжоу

Идентификаторы

NCT: NCT07454720 · SHR-1316-308

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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