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Идёт набор NCT06718543

Neoadjuvant Short-Course Radiotherapy With or Without Chemotherapy and AK112 in Locally Advanced Rectal Cancer

Фаза II С лечением Rectal Cancer

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: AK112 with SCRT and CapeOX, AK112 with SCRT.
Кому может быть актуально
Состояния в реестре: Rectal Cancer. Базовые параметры: 18 лет — 80 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

A Multicenter, Randomized, Parallel, Non-Controlled, Prospective Phase II Study of Neoadjuvant Short-Course Radiotherapy Sequential With AK112 With or Without Chemotherapy for Locally Advanced Rectal Cancer

Обзор

This phase II multicenter, randomized study evaluates the safety and efficacy of neoadjuvant short-course radiotherapy (SCRT) sequentially combined with AK112 (Envafolimab) with or without chemotherapy in patients with locally advanced rectal cancer (LARC). The study also aims to identify biomarkers predicting tumor response and develop efficacy prediction models.

Подробное описание

The study is designed as a two-arm, randomized, open-label, prospective trial. Patients with locally advanced rectal adenocarcinoma will be randomly assigned to one of two treatment groups:

Arm A: SCRT followed by chemotherapy (CapeOX) combined with AK112. Arm B: SCRT followed by AK112 alone. Primary and secondary outcome measures include complete response rate (CR), safety, pathological and radiological response rates, and biomarkers associated with treatment response. The trial will enroll 100 participants across multiple centers over three years.

Вмешательства

  • Препарат AK112 with SCRT and CapeOX
    In the 1st week, neoadjuvant short-course radiotherapy will be administered (25 Gy in 5 fractions over 5 days). After a 7day interval, patients will receive 2 cycles of CapeOX chemotherapy combined with AK112 (every 3 weeks; Day 1: Oxaliplatin, 130 mg/m², IV infusion; Day 1: AK112, 20 mg/kg, IV infusion; Day 1 to Day 14: Capecitabine, 850-1000 mg/m², BID, orally).
  • Препарат AK112 with SCRT
    In the 1st week, neoadjuvant short-course radiotherapy will be administered (25 Gy in 5 fractions over 5 days). After a 7-day interval, patients will receive 2 cycles of AK112 treatment (Day 1: AK112, 20 mg/kg, IV infusion).

Первичные конечные точки

  • Complete Response Rate [Срок оценки: From treatment initiation to post-neoadjuvant therapy evaluation (approximately 12 weeks).]
Вторичные конечные точки (9)
  • Adverse Events (AEs) [Срок оценки: From baseline to 90 days after the last treatment dose.]
  • Major Pathological Response (MPR) [Срок оценки: At the time of surgery (approximately 12 weeks after treatment initiation).]
  • Objective Response Rate (ORR) [Срок оценки: Approximately 12 weeks after treatment initiation.]
  • Progression-Free Survival (PFS) [Срок оценки: Up to 36 months post-randomization.]
  • Overall Survival (OS) [Срок оценки: Up to 36 months post-randomization.]
  • Organ Preservation Rate (OPR) [Срок оценки: Approximately 12 months post-treatment initiation.]
  • Tumor Response Based on RECIST 1.1 [Срок оценки: Approximately 12 weeks after treatment initiation.]
  • Clinical Complete Response Rate (cCR) [Срок оценки: Approximately 12 weeks after treatment initiation.]
  • Pathological Complete Response (pCR) [Срок оценки: Approximately 12 weeks after treatment initiation.]

Критерии участия

Критерии включения

  • Signed written informed consent.
  • Age 18-80 years, male or female.
  • Histologically confirmed rectal adenocarcinoma.
  • Clinical baseline stage T3-4NxM0 or TxN1-2M0 by MRI assessment.
  • Able to swallow tablets.
  • ECOG Performance Status of 0-1.
  • No prior treatment for rectal cancer, including surgery, radiotherapy, 8.chemotherapy, immunotherapy, or targeted therapy.

9.Fit for surgery with no contraindications. 10.Normal organ function. 11.Tumor ≤12 cm from the anal verge

Критерии исключения

  • Allergy to monoclonal antibodies, AK112 components, or CapeOX regimen.
  • Previous or current use of immune checkpoint inhibitors or immune-related 3.treatments.

4.Active autoimmune diseases or history of significant autoimmune conditions. 5.Immunodeficiency disorders or history of organ/bone marrow transplantation. 6.Uncontrolled cardiovascular conditions (e.g., heart failure, unstable angina, recent MI).

7.Severe infection within 4 weeks or active pulmonary infections. 8.Active hepatitis B or C infection. 9.Diagnosis of other malignancies within 5 years (except low-risk cancers). 10.Pregnant or breastfeeding women.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Нерандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Китай · 1 центр
  • Daping Hospital — Чунцин

Идентификаторы

NCT: NCT06718543 · TRIUNITE-03

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗