Clinical trial · Interventional
Camrelizumab Plus Apatinib and Temozolomide as Neoadjuvant in High Risk Acral Melanoma
A Phase 2 Clinical Trial of Neoadjuvant Camrelizumab Plus Apatinib and Temozolomide in High Risk Clinical Stage Ⅱ-Ⅲ Acral Melanoma
NCT05512481CI-TRIAL-00086673recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Neoadjuvant therapy is feasible in stage Ⅱ-Ⅲ melanoma, Carrelizumab combined with apatinib and temozolomide has synergistic antitumor effects and may improve pathological response.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acral Melanoma | Acral Melanoma | ONTOLOGY_EXACT | 0.90 |
| Apatinib | — | UNRESOLVED | — |
| Camrelizumab | — | UNRESOLVED | — |
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
| Neoadjuvant | — | UNRESOLVED | — |
| Pathological Response | — | UNRESOLVED | — |
| Temozolomide | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Camrelizumab | Drug | Camrelizumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Neoadjuvant/adjuvant therapy
- description
- Drug: Camrelizumab Drug: Apatinib mesylate Drug: Temozolomide Injection
- interventionNames
- Drug: Camrelizumab
Primary outcomes (1)
- measure
- Pathological response rate
- timeFrame
- Week 8-12
- description
- The primary endpoint is the pathological response rate at surgery after neoadjuvant study treatment. The pathological response is categorised thus: Complete pathological response (pCR) - 0% viable tumour cells in the surgical specimen Near complete pathological response - (near pCR) - \<10% viable tumour Partial pathological response (pPR) - 10%-50% viable tumour No pathological response (pNR) - \>50% viable tumour
Secondary outcomes (5)
- measure
- Objective Response Rate
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.