Radiotherapy Combined QL1706, TAS-102 and Bevacizumab in mCRC

Официальное название

A Single-Arm, Exploratory Study of Palliative Radiotherapy Combined With Iparomlimab and Tuvonralimab, Trifluridine/Tipiracil (TAS-102), and Bevacizumab in Later-Line Treatment of Advanced Colorectal Cancer

Обзор

This single-center, single-arm, prospective study plans to enroll patients with advanced colorectal cancer who have failed first-line or higher systemic therapies. Participants will receive a combination of iparomlimab and tuvonralimab (QL1706), trifluridine/tipiracil (TAS-102), bevacizumab, and palliative radiotherapy. The efficacy and safety of this combination therapy will be evaluated by assessing objective response rate (ORR), progression-free survival (PFS), overall survival (OS), disease control rate (DCR), and safety profile.

Вмешательства

• Лучевая терапия Palliative radiotherapy
  Conventional fractionation, low-dose hypofractionated radiotherapy, or high-dose hypofractionated radiotherapy may be employed.
• Препарат Iparomlimab and tuvonralimab
  5 mg/kg, intravenously infused on Day 1 of each cycle, administered every 3 weeks (with each cycle defined as 21 days).
• Препарат TAS-102
  35 mg/m², orally twice daily on Days 1 to 5 and Days 8 to 12 of each cycle, with each cycle spanning 28 days (4 weeks).
• Препарат Bevacizumab
  7.5 mg/kg via intravenous infusion on Day 1 of each 21-day cycle.

Первичные конечные точки

• ORR [Срок оценки: approximately 4 months after the last subject participating in]

Вторичные конечные точки (4)

• PFS [Срок оценки: approximately 12 months after the last subject participating in]
• OS [Срок оценки: approximately 12 months after the last subject participating in]
• DCR [Срок оценки: approximately 4 months after the last subject participating in]
• Safety (adverse event) [Срок оценки: Up to approximately 2 years.]

Критерии участия

Критерии включения

• Aged 18 to 75 years .
• Histologically confirmed unresectable colorectal adenocarcinoma.
• Patients must have received at least one prior line of oxaliplatin-, irinotecan-, or 5-FU-based therapy with documented progression or intolerance.
• Documented KRAS and BRAF mutation status (mutant or wild-type) must be available.
• Palliative radiotherapy targeting primary or metastatic lesions is planned.
• At least one measurable lesion per RECIST v1.1 exists.
• ECOG score of 0-1 and life expectancy ≥12 weeks.
• Adequate bone marrow, hepatic, and renal function must be demonstrated.
• Fertile patients commit to using effective contraception during and for 6 months post-treatment.

Критерии исключения

• History of Grade ≥3 immune-related adverse events (irAEs) from prior immunotherapy deemed contraindications for retreatment.
• Radiation or systemic anticancer therapy within 14 days prior to first study treatment.
• Active CNS metastases and/or leptomeningeal disease (LMD). Symptomatic interstitial lung disease (ILD), active pneumonitis, uncontrolled infections, or non-healing wounds/fistulae.
• Intestinal perforation risks: active diverticulitis, intra-abdominal abscess, GI obstruction, or cancer-related peritoneal carcinomatosis.
• Uncontrolled or symptomatic serous cavity effusions (pleural, ascites, pericardial).
• Uncontrolled cardiovascular/cerebrovascular diseases.
• Medical/social conditions that may compromise study results or lead to premature termination per investigator judgment.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Jinan Central Hospital — Цзинань

Идентификаторы

NCT: NCT07116577 · 20250710004

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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