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Tests treatment safety and results for Esophagus Cancer
Official title The Efficacy and Safety of Fosrolapitant and Palonosetron Hydrochloride for Injection in Preventing Nausea and Vomiting Caused by Multi-cycle Immunotherapy and Chemotherapy in Patients With Esophageal Cancer and Lung Cancer
ClinicalTrials.gov ID: NCT07617246
What this study is testing
What is Fosrolapitant and Palonosetron Hydrochloride for Injection combined with dexamethasone acetate?
Fosrolapitant and Palonosetron Hydrochloride for Injection combined with dexamethasone acetate is an investigational medicine, given as a twice-daily infusion into a vein, being studied as a potential treatment for esophagus cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study was a randomized, parallel, cohort study to evaluate the efficacy and safety of Fosrolapitant and Palonosetron Hydrochloride for Injection in preventing nausea and vomiting caused by multi-cycle immunotherapy and chemotherapy in patients with esophageal cancer and lung cancer. A total of 120 subjects are planned to be enrolled, with 60 in each cohort.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥18 years old, gender not limited;
- Histologically or cytologically confirmed untreated locally advanced/metastatic esophageal cancer and lung cancer;
- Has not received any chemotherapy drugs in the past (anti-tumor drugs are not used for cancer treatment);
- Plan to receive at least 4 cycles of chemotherapy combined with immunotherapy based on cisplatin and carboplatin;
- Expected survival period ≥3 months;
You likely can't join if
- Abdominal (including the diaphragmatic plane and below) or pelvic radiotherapy was received within 7 days prior to randomization, or is planned to be...
- It is planned to administer chemotherapy drugs with a high risk of vomiting within 2 to 8 days after platinum infusion.
- Plan to receive chemotherapy regimens including common paclitaxel (using castor oil as the solvent);
- Take drugs with potential antiemetic effects within 2 days before randomization: The first-generation 5-HT3 receptor antagonists (such as...
- Start treatment with benzodiazepines or opioid preparations within 2 days before randomization (except for triazolam, temazepam or midazolam taken...
- people who began using morphine within 7 days before randomization (except those taking a stable dose);
See the full eligibility criteria
- Age ≥18 years old, gender not limited;
- Histologically or cytologically confirmed untreated locally advanced/metastatic esophageal cancer and lung cancer;
- Has not received any chemotherapy drugs in the past (anti-tumor drugs are not used for cancer treatment);
- Plan to receive at least 4 cycles of chemotherapy combined with immunotherapy based on cisplatin and carboplatin;
- Expected survival period ≥3 months;
- Eastern Cooperative Oncology Group (ECOG) Physical Condition score: 0 or 1 point;
- Good organ function, meeting the following criteria:
- Neutrophil count ≥1.5×109/L;
- Hemoglobin ≥ 90g/L;
- Platelet count ≥ 100×109/L;
- Total bilirubin ≤1.5×ULN In patients without known liver metastases, aspartate aminotransferase ≤2.5×ULN and/or alanine aminotransferase ≤2.5×ULN (for patients with liver metastases, it can be relaxed to ≤5×ULN); f...
- Fertile female people and male people whose partners are fertile women need to adopt an effective contraceptive measure from the time of signing the informed consent form until 6 months after the last administration...
- Clearly understand and voluntarily participate in this research, and sign the informed consent form by oneself.
- Abdominal (including the diaphragmatic plane and below) or pelvic radiotherapy was received within 7 days prior to randomization, or is planned to be received within 1 to 8 days of treatment;
- It is planned to administer chemotherapy drugs with a high risk of vomiting within 2 to 8 days after platinum infusion.
- Plan to receive chemotherapy regimens including common paclitaxel (using castor oil as the solvent);
- Take drugs with potential antiemetic effects within 2 days before randomization: The first-generation 5-HT3 receptor antagonists (such as ondansetron), phenthiazide drugs (such as prochlorazine), butanylbenzene drugs...
- Start treatment with benzodiazepines or opioid preparations within 2 days before randomization (except for triazolam, temazepam or midazolam taken alone daily);
- people who began using morphine within 7 days before randomization (except those taking a stable dose);
- Within 7 days before randomization, systemic corticosteroid therapy (including but not limited to dexamethasone, hydrocortisone, methylprednisolone or prednisolone) or sedative antihistamines (such as diphenhydramine)...
- Palonosetron was used within 14 days prior to randomization;
- Use NK-1 receptor antagonists within 28 days before randomization;
- Specific CYP3A4 substrates (terfenadine, cisapride, asemidazole) or CYP3A4 inhibitors (such as ritonavir, clarithromycin, ketoconazole or itraconazole, diltiazem, etc.) were used within 7 days before randomization...
- Vomiting and/or retching and nausea occurred within 24 hours before randomization; people with symptomatic brain metastases;
- Accompanied by poorly controlled serous cavity effusion, including pleural effusion, ascites, and pericardial effusion (those that have been controlled after treatment and remained stable for ≥2 weeks can be included);
- Having severe cardiovascular diseases within 3 months prior to randomization, including but not limited to acute myocardial infarction, unstable angina pectoris, significant valvular or pericardial disease, history of...
- Poorly controlled hypertension (two consecutive resting systolic blood pressures ≥160mmHg and/or diastolic blood pressures ≥100mmHg) before randomization;
- Those with combined active hepatitis B (HBV DNA≥2000 IU/mL or 104 copies/mL), active hepatitis C (HCV-Ab positive and HCV-RNA≥ upper limit of normal value), acquired immune deficiency syndrome (AIDS) or positive HIV...
- Concomitant diseases that prevent dexamethasone from being taken, such as active infections (like pneumonia) or any uncontrolled diseases (such as diabetic ketoacidosis, gastrointestinal obstruction, etc.);
- Known contraindications of NK-1 receptor antagonists, 5-HT3 receptor antagonists or dexamethasone;
- Having participated in other clinical trials within 30 days prior to randomization (based on the use of the study drug);
- people who the researchers consider to have other circumstances that make them unsuitable to participate in this study.
The study team makes the final eligibility decision.
Where it's taking place
- Hangzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hangzhou, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.