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
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- ORR
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Experimental Arm
Palliative radiotherapy combined with iparomlimab and tuvonralimab (QL1706), trifluridine/tipiracil (TAS-102), and bevacizumab.
干预措施: Palliative radiotherapy (Radiation)
Experimental Arm
Palliative radiotherapy combined with iparomlimab and tuvonralimab (QL1706), trifluridine/tipiracil (TAS-102), and bevacizumab.
干预措施: Iparomlimab and tuvonralimab (Drug)
Experimental Arm
Palliative radiotherapy combined with iparomlimab and tuvonralimab (QL1706), trifluridine/tipiracil (TAS-102), and bevacizumab.
干预措施: TAS-102 (Drug)
Experimental Arm
Palliative radiotherapy combined with iparomlimab and tuvonralimab (QL1706), trifluridine/tipiracil (TAS-102), and bevacizumab.
干预措施: Bevacizumab (Drug)
结局指标
主要结局
ORR
时间窗: approximately 4 months after the last subject participating in
The time from the date for first documented response of complete response (CR) or partial response (PR) to the date of first documented of disease progression or death, whichever occurs first.
次要结局
- PFS(approximately 12 months after the last subject participating in)
- OS(approximately 12 months after the last subject participating in)
- DCR(approximately 4 months after the last subject participating in)
- Safety (adverse event)(Up to approximately 2 years.)
研究者
Meili Sun
Director of Department of Oncology
Jinan Central Hospital