Combination of Carilizumab, Apatinib, and Radiotherapy for Advanced Mucosal Melanoma

November 14, 2025 updated by: Zhengyun Zou, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

A Prospective, Multicenter, Single Arm, Open Label Clinical Study Evaluating the Efficacy and Safety of the Combination of Carilizumab With Apatinib Mesylate and Radiotherapy in the First-line Treatment of Advanced Mucosal Melanoma

This study is a prospective, multicenter, single arm, open label study aimed at evaluating the efficacy and safety of the combination of Carilizumab, Apatinib Mesylate, and first-line radiotherapy for advanced mucosal melanoma.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study is a prospective, multicenter, single arm, open label study aimed at evaluating the efficacy and safety of the combination of Carilizumab, Apatinib Mesylate, and first-line radiotherapy for advanced mucosal melanoma. The study will use the 6-month progression free survival rate (PFS6) as the primary efficacy indicator and plan to enroll approximately 30 non-surgical first-line treatment subjects with mucosal melanoma. After being fully informed and signing informed consent forms, the subjects will be screened and qualified to receive the following treatments: Induction phase (2 cycles): 200mg of Carilizumab, intravenous infusion, administered once every 2 weeks, with a 4-week cycle; Apatinib mesylate 500mg, oral, once daily, adjusted according to patient tolerance, with a 4-week cycle; Completed 2 cycles in total. ·Synchronous radiotherapy stage: 200mg of Carilizumab is administered intravenously once every 2 weeks, with a 4-week cycle; Apatinib mesylate 500mg, oral, once daily, adjusted according to patient tolerance, with a 4-week cycle; The radiation therapy plan evaluated by the researchers: the radiation dose and radiation field are determined by the researchers, with an overall principle of 18-25Gy/3-6f, or equivalent BED. Three dimensional conformal radiotherapy (3D-CRT) or intensity-modulated conformal radiotherapy (IMRT) techniques are used for radiotherapy. Radiotherapy should be scheduled before the use of PD-1 antibody Carilizumab, and intravenous infusion of Carilizumab should be administered within 48 hours after the end of radiotherapy. If there are multiple lesions that can be treated with radiotherapy, after evaluation by the research team, sequential radiotherapy for multiple lesions is allowed based on the lesion location and the tolerance of surrounding normal organs. ·Maintenance phase: Carilizumab 200mg, intravenous infusion, administered once every 2 weeks, with a 4-week cycle; Apatinib mesylate 500mg, oral, once daily, adjusted according to patient tolerance, with a 4-week cycle; Until tumor progression, intolerance, initiation of other anti-tumor treatments, loss to follow-up, or death. The cumulative maximum shall not exceed 2 years. After the completion of treatment, subjects will continue to undergo post-treatment safety and survival follow-up. For subjects who have completed treatment due to non disease progression/death reasons, tumor progression follow-up will also be conducted after the completion of treatment. Safety visit: After the subjects are enrolled in the study, safety visits will be conducted at each treatment cycle D1 and at the end of treatment visit. Imaging assessment: All lesions were recorded and evaluated according to RECIST 1.1. The window period allowed for imaging examinations is ± 7 days unless otherwise specified. During the research period, unplanned imaging examinations may be performed when tumor progression is suspected. The assessment of tumor baseline within 4 weeks before enrollment, CT/MRI scan results obtained before signing informed consent can be used for screening tumor assessment as long as they meet the requirements; Suspected brain metastases require enhanced MRI/CT of the brain to rule out brain metastases. When there is a clear or clinical suspicion of bone metastasis, bone scan examination should be performed to exclude bone metastasis. Within 12 months after the first administration, imaging examinations should be conducted every 2 cycles (± 7 days). After 12 months, imaging examinations should be conducted every 3 cycles (± 7 days). If there is suspicion of metastasis to other areas, additional imaging examinations for that area should be performed. After terminating the study treatment, subjects who did not show imaging progression continued to undergo imaging evaluation at the frequency of the treatment period until imaging progression, acceptance of other anti-tumor treatments, withdrawal of informed consent, loss to follow-up, or death occurred. Survival follow-up: After the completion or withdrawal of the study, survival and post study information will be collected through telephone follow-up every 3 months until death, loss to follow-up, withdrawal of informed consent, observation for 1 year, or termination of the study by the researcher.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age ≥ 18 years old, ≤ 80 years old, gender not limited
  2. Confirmed by pathological histology, patients with recurrent, unresectable, or metastatic mucosal melanoma after surgery
  3. In the late stage, no systemic anti-tumor drug treatment has been received, and previous radical surgical resection, adjuvant or neoadjuvant therapy is allowed. However, it is required to be completed at least 4 weeks before randomization, and all treatment-related toxicity events have returned to normal or CTCAE 5.0 grade I or below (except for hair loss, skin hypopigmentation, well controlled hypothyroidism, and adrenal insufficiency)
  4. There must be at least one measurable lesion that has not undergone local treatment (according to RECIST v1.1 requirements, the length of the measurable lesion on spiral CT or MRI scan must be ≥ 10 mm or the length of enlarged lymph nodes must be ≥ 15 mm)
  5. At least one lesion that can receive radiotherapy
  6. ECOG PS 0 or 1 point
  7. Expected survival period ≥ 12 weeks
  8. No contraindications for treatment, with sufficient organ and bone marrow function: ① Absolute neutrophil count ≥ 1.5 × 109/L ② Platelets ≥ 80 × 109/L③ Hemoglobin ≥ 90 g/L④ ALT and AST ≤ 1.5 × ULN⑤ Bilirubin ≤ 1.5 × ULN⑥ Blood creatinine ≤ 1.5 × ULN
  9. Patients may have a history of brain/meningeal metastases, but they must have undergone local treatment (surgery/radiation therapy) before the start of the study and have been clinically stable for at least 3 months (corticosteroids are allowed to be used before randomization, but must be discontinued 2 weeks before starting the study drug)
  10. Non surgical sterilization or female patients of childbearing age are required to use a medically approved contraceptive measure (such as intrauterine device, contraceptive pill, or condom) during the study treatment period and within 12 months after the end of the study treatment period
  11. For male patients whose partners are women of childbearing age, effective contraception methods should be used during the trial period and within 12 months after the last dose. 11. Participants voluntarily join the study, sign informed consent forms, have good compliance, and cooperate with follow-up.

Exclusion Criteria:

  1. Patients who have received VEGFR TKI treatment within the past 6 months (including neoadjuvant and adjuvant treatment periods)
  2. Individuals known to be allergic to recombinant humanized anti-PD-1 monoclonal antibody drugs and their components
  3. History of immunodeficiency, or other acquired or congenital immunodeficiency diseases, or history of organ transplantation
  4. Previous thyroid dysfunction and inability to maintain normal thyroid function even with medication treatment
  5. Pregnant or lactating women
  6. Evidence of bleeding quality or significant coagulation dysfunction (not receiving anticoagulant therapy)
  7. Bleeding events occurring within 6 months prior to the first medication due to untreated or incompletely treated esophageal and/or gastric varices
  8. Major vascular disease (such as aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis) occurred within 6 months before the first use of medication
  9. Insufficient control of hypertension (systolic blood pressure ≥ 140mmHg or diastolic blood pressure ≥ 90mmHg) (based on the average of BP readings obtained from ≥ 2 measurements), allowing for the use of antihypertensive therapy to achieve the above parameters
  10. Previously experienced hypertensive crisis or hypertensive encephalopathy
  11. Within the past 3 months, there has been severe cardiovascular disease (such as New York Heart Association Grade II or above heart disease, myocardial infarction, or cerebrovascular accident), unstable arrhythmia, or unstable angina pectoris
  12. Severe, unhealed, or cracked wounds, active ulcers, or untreated fractures
  13. Perform hollow needle biopsy or other minor surgery within 3 days before the first medication, excluding the placement of vascular access devices
  14. Major surgery should be performed within 4 weeks before the first medication, or expected to be required during the study period
  15. Those who have been treated with systemic immunosuppressive drugs (including but not limited to glucocorticoids [>10 mg/d prednisone or other corticosteroids with equivalent physiological doses], cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor alpha [TNF - α] preparations) within 2 weeks prior to their first medication, or who are expected to require systemic immunosuppressive drugs during the study treatment period
  16. Subjects who have received or will receive a live vaccine within 30 days prior to the first dose, or who are expected to use the vaccine during the expected treatment period or within 5 months after the last dose

176. Individuals known to be allergic to any investigational drug or excipient

18. Individuals with a history of abuse of psychotropic drugs who are unable to quit or have mental disorders

19. Researchers determine other situations that are not suitable for inclusion in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Combination of Carilizumab with Apatinib Mesylate and Radiotherapy
Drug: Carilizumab and Apatinib
Carilizumab 200mg, intravenous infusion, administered once every 2 weeks, with a 4-week cycle; Apatinib mesylate 500mg, oral, once daily, adjusted according to patient tolerance, with a 4-week cycle; Completed 2 cycles in total. ·Synchronous radiotherapy stage: 200mg of Carilizumab is administered intravenously once every 2 weeks, with a 4-week cycle; Apatinib mesylate 500mg, oral, once daily, adjusted according to patient tolerance, with a 4-week cycle;

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
6-month progression free survival rate
Time Frame: From the day each patient starts treatment until the 6th month (180 days).
From the day each patient starts treatment until the 6th month (180 days).

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Overall survival, OS
Time Frame: every 3 months after the patient completed the trial treatment
every 3 months after the patient completed the trial treatment
Disease control rate,DCR
Time Frame: The subjects must be confirmed at least 4 weeks ± 7 days after the initial evaluation.
The subjects must be confirmed at least 4 weeks ± 7 days after the initial evaluation.
objective response rate
Time Frame: The subjects must be confirmed at least 4 weeks ± 7 days after the initial evaluation.
The subjects must be confirmed at least 4 weeks ± 7 days after the initial evaluation.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 30, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 28, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 14, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 19, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 19, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 14, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2025-0433-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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