Status:

RECRUITING

Camrelizumab Plus Apatinib and Temozolomide as Neoadjuvant in High Risk Acral Melanoma

Lead Sponsor:

Peking University Cancer Hospital & Institute

Conditions:

Melanoma

Acral Melanoma

Eligibility:

All Genders

18-75 years

Phase:

PHASE2

Brief Summary

Neoadjuvant therapy is feasible in stage Ⅱ-Ⅲ melanoma, Carrelizumab combined with apatinib and temozolomide has synergistic antitumor effects and may improve pathological response.

Detailed Description

Patients with resectable melanoma can benefit from neoadjuvant therapy, including improved surgical outcomes, precise management of patients based on neoadjuvant response, and analysis of resistance m...

Eligibility Criteria

Inclusion Criteria:

  1. age:18-75 years, male or female.
  2. Histopathologically confirmed acral melanoma (stage Ⅱ/Ⅲ).
  3. Has not received any systematic anti-tumor drug treatment.
  4. Measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1.
  5. ECOG 0-1.
  6. Adequate organ function.
  7. Life expectancy of greater than 12 weeks.
  8. Patient has given written informed consent.

Exclusion Criteria:

  1. Patients who have or are currently undergoing additional chemotherapy, radiation therapy, targeted therapy or immunotherapy.
  2. Known history of hypersensitivity to any component of apatinib, temozolomide, Camrelizumab.
  3. Subjects before or at the same time with other malignant tumors (except which has cured skin basal cell carcinoma and cervical carcinoma in situ);
  4. Subjects with any active autoimmune disease or history of autoimmune disease
  5. Patients with any unstable systemic disease, including but not limited to: serious infection, uncontrolled diabetes, unstable angina pectoris, cerebrovascular accident or transient ischemic attack, myocardial infarction, congestive heart failure, serious cardiac arrhythmia requiring medication, hepatic, renal or metabolic disease;
  6. Received a live vaccine within 4 weeks of the first dose of study medication.
  7. Pregnancy or breast feeding.
  8. Decision of unsuitableness by principal investigator or physician-in charge.

Key Trial Info

Start Date :

September 13 2022

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 31 2026

Estimated Enrollment :

60 Patients enrolled

Trial Details

Trial ID

NCT05512481

Start Date

September 13 2022

End Date

December 31 2026

Last Update

March 3 2025

Active Locations (1)

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1

Beijing Cancer Hospital

Beijing, Beijing Municipality, China