Health TrialsbyHealthPanel

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

ConditionMucosal Melanoma
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years old, ≤ 80 years old, gender not limited

Confirmed by pathological histology, patients with recurrent, unresectable, or metastatic mucosal melanoma after surgery

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)

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)

Disqualifiers

Patients who have received VEGFR TKI treatment within the past 6 months (including neoadjuvant and adjuvant treatment periods)

Individuals known to be allergic to recombinant humanized anti-PD-1 monoclonal antibody drugs and their components

History of immunodeficiency, or other acquired or congenital immunodeficiency diseases, or history of organ transplantation

Previous thyroid dysfunction and inability to maintain normal thyroid function even with medication treatment

Trial design

Design model

Single group

Treatments tested in this trial

  • Carilizumab and Apatinib

    Drug

    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;

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Combination of Carilizumab with Apatinib Mesylate and RadiotherapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

6-month progression free survival rate

Time frame
From the day each patient starts treatment until the 6th month (180 days).

Secondary outcomes

1

Overall survival, OS

Time frame
every 3 months after the patient completed the trial treatment
2

Disease control rate,DCR

Time frame
The subjects must be confirmed at least 4 weeks ± 7 days after the initial evaluation.
3

objective response rate

Time frame
The subjects must be confirmed at least 4 weeks ± 7 days after the initial evaluation.

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: