Esophagus CancerPhase 2NCT07617246
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 Phase 2 study testing Fosrolapitant and Palonosetron Hydrochloride for Injection combined with dexamethasone acetate and For injection, fosapirtan dimeglumine combined with palonosetron hydrochloride and dexamethasone acetate in people with Esophagus Cancer and Lung Cancer, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophagus Cancer, Lung Cancer
- What is being tested?
- Fosrolapitant and Palonosetron Hydrochloride for Injection combined with dexamethasone acetate and For injection, fosapirtan dimeglumine combined with palonosetron hydrochloride and dexamethasone acetate
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2025to 31 Jan 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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: Serum creatinine ≤1.5×ULN or creatinine clearance rate ≥ 50ml/min; g: Electrocardiogram: QTc≤450ms (for males), QTc≤470ms (for females); h: Cardiac color Doppler ultrasound: LVEF (left ventricular ejection fraction) ≥50%;
- Fertile female subjects and male subjects 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. Female subjects with fertility must have a negative blood pregnancy test within 72 hours before randomization. And it must be non-lactation period;
- Clearly understand and voluntarily participate in this research, and sign the informed consent form by oneself.
Who cannot join
- 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 (such as haloperidol), benzamides (such as metoclopramide), domperidone, cannabinoids, traditional Chinese medicines with potential antiemetic effects, scopolamine, cyclezine, etc.
- Start treatment with benzodiazepines or opioid preparations within 2 days before randomization (except for triazolam, temazepam or midazolam taken alone daily);
- Subjects who began using morphine within 7 days before randomization (except those taking a stable dose);
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- Within 7 days before randomization, systemic corticosteroid therapy (including but not limited to dexamethasone, hydrocortisone, methylprednisolone or prednisolone) or sedative antihistamines (such as diphenhydramine) were received (Note: Single use of steroids is allowed to prevent contrast agent allergy and local administration or inhalation), except for those who need hormone pretreatment one day before chemotherapy.
- 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. Strong CYP3A4 inducers (such as phenobarbital, rifampicin, phenytoin and carbamazepine) or specific CYP2D6 substrates (thiolidazine, pimozide) were used within 28 days before randomization;
- Vomiting and/or retching and nausea occurred within 24 hours before randomization; Subjects 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 ventricular tachycardia, symptomatic chronic heart failure (New York Heart Association [NYHA] grades II to IV), and history of severe cardiac conduction abnormalities (such as torus cuspidata ventricular tachycardia);
- 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 test, and positive syphilis test;
- 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);
- Subjects who the researchers consider to have other circumstances that make them unsuitable to participate in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
SAHZhejiangU
Hangzhou, Zhejiang, 313000
youping wang, 8615995830219, 349084003@qq.com
About this study
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. 40% of the subjects will undergo an interim analysis upon completion of the study.
The trial consists of a screening period, a treatment period and a safety follow-up period. Drug treatment was administered in accordance with the trial protocol, and then the corresponding follow-up and examination were completed in accordance with the trial process table. During the research period, if the researcher assesses that the subjects indeed need to use remedial antiemetic drugs, remedial treatment can be carried out based on clinical practice. The specific types, usage, dosage and frequency of the drugs are determined by the researcher.
- Conditions
- Esophagus Cancer, Lung Cancer
- Being tested
- Fosrolapitant and Palonosetron Hydrochloride for Injection combined with dexamethasone acetate, For injection, fosapirtan dimeglumine combined with palonosetron hydrochloride and dexamethasone acetate
- Medical subject headings
- Esophageal Neoplasms, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fosrolapitant and Palonosetron Hydrochloride for Injection combined with dexamethasone acetateDrug
Fosrolapitant and Palonosetron Hydrochloride for Injection: Intravenous drip for 1 hour (+10 minutes), once before each cycle of chemotherapy.
Dexamethasone acetate: Take 12mg orally on the first day of each chemotherapy cycle before chemotherapy, and 3.75mg orally on the second to fourth days twice a day.
For injection, fosapirtan dimeglumine combined with palonosetron hydrochloride and dexamethasone acetateDrug
Fosapirtan dimeglumine for injection: 150mg, intravenous drip for 20-30 minutes, administered once before each cycle of chemotherapy.
Palonosetron hydrochloride: 0.25mg, intravenous injection for at least 30 seconds, administered once before each cycle of chemotherapy.
Dexamethasone acetate: Take 6mg orally on the first day of each chemotherapy cycle before chemotherapy, 3.75mg orally once on the second day, and 3.75mg orally every day from the third to the fourth day.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Fosrolapitant and Palonosetron Hydrochloride for Injection combined with dexamethasone acetate Receives: Drug: Fosrolapitant and Palonosetron Hydrochloride for Injection combined with dexamethasone acetate |
| 2 | Placebo comparator | For injection, fosapirtan dimeglumine combined with palonosetron hydrochloride and dexamethasone acetate Receives: Drug: For injection, fosapirtan dimeglumine combined with palonosetron hydrochloride and dexamethasone acetate |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of subjects who achieved complete remission (CR: no vomiting and remedial treatment) in the super-delayed period (120 hour-168 hour) after the start of each immunotherapy combined with chemotherapy cycle;
Measured: The super-delayed period (120 hour-168 hour) after the start of each immunotherapy combined with chemotherapy cycle，each cycle is 21 days. Total of 4 treatment cycles of immunotherapy combined with chemotherapy were observed.
Secondary outcomes (3)
The CR rate in the acute phase (0 hour-24 hour), delayed phase (24 hour-120 hour), overall phase (0 hour-120 hour), and 0 hour-168 hour of each immunotherapy combined with chemotherapy cycle;
Measured: Each cycle is 21 days. Total of 4 treatment cycles of immunotherapy combined with chemotherapy were observed.
The time of the first vomiting
The time of the first vomiting was compared through the Kaplan-Meier curv
Measured: Each cycle is 21 days. Total of 4 treatment cycles of immunotherapy combined with chemotherapy were observed.
The impact of chemotherapy-induced nausea and vomiting (CINV) on quality of life
The impact of chemotherapy-induced nausea and vomiting (CINV) on quality of life was evaluated by functional life Index - Vomiting (FLIE)
Measured: Each cycle is 21 days. Total of 4 treatment cycles of immunotherapy combined with chemotherapy were observed.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2026
- Study start1 Nov 2025
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophagus CancerStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07617246
- Sponsor's protocol ID
- FEAL
- Status last verified
- Oct 2025
- First submitted
- 7 Dec 2025
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- Acronym / sponsor ID
- FEAL
- Conditions
- Esophagus Cancer, Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 1 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. 40% of the subjects will undergo an interim analysis upon completion of the study.
The trial consists of a screening period, a treatment period and a safety follow-up period. Drug treatment was administered in accordance with the trial protocol, and then the corresponding follow-up and examination were completed in accordance with the trial process table. During the research period, if the researcher assesses that the subjects indeed need to use remedial antiemetic drugs, remedial treatment can be carried out based on clinical practice. The specific types, usage, dosage and frequency of the drugs are determined by the researcher.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Fosrolapitant and Palonosetron Hydrochloride for Injection combined with dexamethasone acetateFosrolapitant and Palonosetron Hydrochloride for Injection combined with dexamethasone acetate |
| 2 | Placebo comparator | Drug: For injection, fosapirtan dimeglumine combined with palonosetron hydrochloride and dexamethasone acetateFor injection, fosapirtan dimeglumine combined with palonosetron hydrochloride and dexamethasone acetate |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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;
Key exclusion criteria (19 listed)
- 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 (such as haloperidol), benzamides (such as metoclopramide), domperidone, cannabinoids, traditional Chinese medicines with potential antiemetic effects, scopolamine, cyclezine, etc.
- Start treatment with benzodiazepines or opioid preparations within 2 days before randomization (except for triazolam, temazepam or midazolam taken alone daily);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fosrolapitant and Palonosetron Hydrochloride for Injection combined with dexamethasone acetateFosrolapitant and Palonosetron Hydrochloride for Injection: Intravenous drip for 1 hour (+10 minutes), once before each cycle of chemotherapy. Dexamethasone acetate: Take 12mg orally on the first day of each chemotherapy cycle before chemotherapy, and 3.75mg orally on the second to fourth days twice a day. | Drug | 1 |
| For injection, fosapirtan dimeglumine combined with palonosetron hydrochloride and dexamethasone acetateFosapirtan dimeglumine for injection: 150mg, intravenous drip for 20-30 minutes, administered once before each cycle of chemotherapy. Palonosetron hydrochloride: 0.25mg, intravenous injection for at least 30 seconds, administered once before each cycle of chemotherapy. Dexamethasone acetate: Take 6mg orally on the first day of each chemotherapy cycle before chemotherapy, 3.75mg orally once on the second day, and 3.75mg orally every day from the third to the fourth day. | Drug | 2 |
Primary outcome
The proportion of subjects who achieved complete remission (CR: no vomiting and remedial treatment) in the super-delayed period (120 hour-168 hour) after the start of each immunotherapy combined with chemotherapy cycle;
Time frame: The super-delayed period (120 hour-168 hour) after the start of each immunotherapy combined with chemotherapy cycle，each cycle is 21 days. Total of 4 treatment cycles of immunotherapy combined with chemotherapy were observed.
3 secondary outcomes
The CR rate in the acute phase (0 hour-24 hour), delayed phase (24 hour-120 hour), overall phase (0 hour-120 hour), and 0 hour-168 hour of each immunotherapy combined with chemotherapy cycle;
Time frame: Each cycle is 21 days. Total of 4 treatment cycles of immunotherapy combined with chemotherapy were observed.
The time of the first vomiting
Time frame: Each cycle is 21 days. Total of 4 treatment cycles of immunotherapy combined with chemotherapy were observed.
The impact of chemotherapy-induced nausea and vomiting (CINV) on quality of life
Time frame: Each cycle is 21 days. Total of 4 treatment cycles of immunotherapy combined with chemotherapy were observed.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fosrolapitant and Palonosetron Hydrochloride for Injection combined with dexamethasone acetate and For injection, fosapirtan dimeglumine combined with palonosetron hydrochloride and dexamethasone acetate in people with Esophagus Cancer and Lung Cancer, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact LIPING WANG (18358147489, 2315124@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of subjects who achieved complete remission (CR: no vomiting and remedial treatment) in the super-delayed period (120 hour-168 hour) after the start of each immunotherapy combined with chemotherapy cycle; (time frame: The super-delayed period (120 hour-168 hour) after the start of each immunotherapy combined with chemotherapy cycle，each cycle is 21 days. Total of 4 treatment cycles of immunotherapy combined with chemotherapy were observed.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.