A Cohort Study of the Combination Regimen Based on Rolapitant and Palonosetron for the Prevention of Nausea and Vomiting Induced by Concurrent Chemoradiotherapy in Lung Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 238
- 主要终点
- Complete Remission (CR) Rate
研究概览
简要总结
This study aims to evaluate the efficacy and safety of a combination regimen based on Rolapitant Palonosetron injection for preventing nausea and vomiting induced by concurrent chemoradiotherapy in lung cancer patients. It will also analyze the differences in preventive efficacy between two combination regimens, filling the gap in antiemetic data for radiotherapy combined with moderately to highly emetogenic chemotherapy. This research will provide evidence for optimizing antiemetic strategies in patients undergoing concurrent chemoradiotherapy.
详细描述
Rolapitant Palonosetron is a combination formulation containing 218 mg of foslora-palanitapentan and 0.25 mg of palo-nexon. It integrates an NK1 receptor antagonist (rolapitant) with a second-generation 5-HT3 receptor antagonist (palonosetron). This dual mechanism simultaneously blocks 5-HT3 and NK-1 pathways, inhibiting the vomiting reflex through dual pathways to provide long-lasting antiemetic efficacy.
The injectable formulation of Rolapitant Palonosetron exhibits an exceptionally long half-life of 188 hours. The PROFIT study demonstrated that a single injection per cycle provides coverage across the acute, delayed, and ultra-delayed phases of CINV, offering sustained protection for up to 8 days. It achieved a complete response (CR) rate exceeding 90% in both the acute and ultra-delayed phases across two consecutive chemotherapy cycles.
Existing studies predominantly focus on chemotherapy-only populations, with limited prospective data for concurrent chemoradiotherapy patients. The efficacy of currently used triple/quadruple antiemetic regimens in this setting requires further investigation, particularly the novel prophylactic strategy combining Rolapitant Palonosetron with dexamethasone ± olanzapine. Against this backdrop, this study aims to evaluate the efficacy and safety of a combination regimen based on Rolapitant Palonosetron injection for preventing nausea and vomiting induced by concurrent chemoradiotherapy in lung cancer patients. It will also analyze the differences in preventive efficacy between two combination regimens, filling the gap in antiemetic data for radiotherapy combined with moderately to highly emetogenic chemotherapy. This research will provide evidence for optimizing antiemetic strategies in patients undergoing concurrent chemoradiotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years, no gender restrictions;
- •Histopathologically or cytologically confirmed lung cancer;
- •Planned to receive concurrent chemoradiotherapy for at least 6 weeks, with radiotherapy administered in conventional fractions (2.0-2.2 Gy/fraction, 5 fractions/week, total dose 60-66 Gy); chemotherapy regimen includes highly emetogenic agents (e.g., cisplatin ≥60 mg/m²) ;
- •ECOG Performance Status score: 0-1;
- •Expected survival >12 weeks;
- •Adequate organ and bone marrow function;
- •Willingness to complete daily nausea/vomiting logs and scale assessments.
排除标准
- •Patients with imaging-confirmed brain metastases accompanied by symptoms of increased intracranial pressure (e.g., headache, vomiting, papilledema) or objective evidence of elevated intracranial pressure.
- •Patients with a documented history of severe hypersensitivity to the active ingredient or excipients of the drug.
- •Known contraindications to NK-1 receptor antagonists, 5-HT3 receptor antagonists, dexamethasone, or olanzapine;
- •Vomiting symptoms (≥1 episode/day) or VAS score ≥30 mm within 7 days prior to first administration;
- •Use of medications with potential antiemetic effects within 2 days prior to first dose: first-generation 5-HT3 receptor antagonists (e.g., ondansetron), phenothiazines (e.g., prochlorperazine), butyrophenones (e.g., haloperidol), benzamides (e.g., metoclopramide), domperidone, cannabinoids, traditional Chinese medicines with potential antiemetic effects, scopolamine, secloperazine, etc.;
- •Presence of conditions affecting vomiting assessment, such as gastrointestinal obstruction, gastroparesis, or intestinal obstruction;
- •History of epilepsy or current use of antiepileptic drugs;
- •Pregnant or lactating women;
- •History of severe psychiatric disorders, substance abuse, alcoholism, or drug addiction;
- •Currently participating in another interventional clinical trial, or having received treatment with another investigational drug or device within 4 weeks prior to the first dose (subjects who failed screening for another clinical trial may be included in this study);
- •Presence of any other factors deemed by the investigator to increase study risk, compromise patient compliance with the protocol, or affect the patient's ability to complete the trial, such as physiological or psychological conditions;
研究组 & 干预措施
Rolapitant Palonosetron + DEX group
D1: 1 hour prior to chemotherapy administration: Rolapitant Palonosetron (Rolapitant 218 mg and Palonosetron Hydrochloride 0.25 mg), IV; 30 minutes prior to chemotherapy: DEX 12 mg, PO, QD;D2-D4: DEX 3.75 mg, PO, BID;
干预措施: Rolapitant Palonosetron (Drug)
Rolapitant Palonosetron + DEX group
D1: 1 hour prior to chemotherapy administration: Rolapitant Palonosetron (Rolapitant 218 mg and Palonosetron Hydrochloride 0.25 mg), IV; 30 minutes prior to chemotherapy: DEX 12 mg, PO, QD;D2-D4: DEX 3.75 mg, PO, BID;
干预措施: Dexamethasone (Drug)
Rolapitant Palonosetron + DEX + Olanzapine group
• D1: 1 hour prior to chemotherapy administration: Rolapitant Palonosetron (Rolapitant 218 mg and Palonosetron Hydrochloride 0.25 mg), IV; 30 minutes prior to chemotherapy: DEX 12 mg, PO, QD;
- D2-D4: DEX 3.75 mg, PO, BID;
- Olanzapine: 5 mg orally, QN, starting the night before the first chemotherapy session and continuing until 2 days after chemotherapy completion;
干预措施: Rolapitant Palonosetron (Drug)
Rolapitant Palonosetron + DEX + Olanzapine group
• D1: 1 hour prior to chemotherapy administration: Rolapitant Palonosetron (Rolapitant 218 mg and Palonosetron Hydrochloride 0.25 mg), IV; 30 minutes prior to chemotherapy: DEX 12 mg, PO, QD;
- D2-D4: DEX 3.75 mg, PO, BID;
- Olanzapine: 5 mg orally, QN, starting the night before the first chemotherapy session and continuing until 2 days after chemotherapy completion;
干预措施: Dexamethasone (Drug)
Rolapitant Palonosetron + DEX + Olanzapine group
• D1: 1 hour prior to chemotherapy administration: Rolapitant Palonosetron (Rolapitant 218 mg and Palonosetron Hydrochloride 0.25 mg), IV; 30 minutes prior to chemotherapy: DEX 12 mg, PO, QD;
- D2-D4: DEX 3.75 mg, PO, BID;
- Olanzapine: 5 mg orally, QN, starting the night before the first chemotherapy session and continuing until 2 days after chemotherapy completion;
干预措施: Olanzapine (Drug)
结局指标
主要结局
Complete Remission (CR) Rate
时间窗: within 6 weeks
The proportion of patients who did not experience vomiting and did not require rescue therapy during concurrent chemoradiotherapy
次要结局
- Complete Protection (CP) Rate(within 6 weeks)
- Total Control (TC) Rate(within 6 weeks)
- Incidence of adverse events (AE)(within 6 weeks)
研究者
LijuanChen
Clinical Professor
Henan Cancer Hospital