Conjunctival melanoma
Conditions
Interventions
Experimental group:Oral Dabrafenib+Intravenous Camrelizumab
Sponsors
Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. The patient voluntarily joined the study and signed the informed consent form; 2. Age 18-75 years old, gender unlimited; 3. Patients with conjunctival melanoma with stage T2/3N0-1M0 can be completely resected in situ tumor and local lymph node metastasis (patients with stage T1 who have local lymph node metastasis after complete resection of tumor and have been completely resected can also be included); 4. There are lesions (primary or affected lymph nodes) that can detect BRAF-V600 mutations, and the results of gene detection are BRAF-V600 mutations; 5. The ECOG physical condition score of the Eastern Cancer Cooperation Organization is 0 or 1; 6. Baseline organ function is sufficient; 7. No gastrointestinal abnormalities with clinical significance; 8. Women with fertility have negative serum pregnancy test results and agree to contraception; 9. Willing to follow up and able to follow up at the specified time.
Exclusion criteria
Exclusion criteria: 1. Non-conjunctival melanoma; 2. Those who have received BRAF/MEK inhibitor treatment within 4 weeks before the test; 3. Those who are in immunosuppressive state or have received immunosuppressive therapy such as systemic steroids within 7 days before the test; 4. Those who have received anti-tumor monoclonal antibody treatment within 4 weeks before the test, or have not recovered from adverse events of other anti-tumor monoclonal antibody treatment; 5. Patients with active autoimmune diseases requiring systemic treatment, patients with clinically severe autoimmune diseases, and patients with symptoms requiring systemic steroid or immunosuppressive therapy within the past three months; 6. Active infected persons who need systematic treatment; 7. Those who have known other progressive malignant tumors and need active treatment, excluding patients with skin BCC, SCC and cervical cancer in situ who have received effective treatment; 8. Schizophrenia, drug abuse disorders, etc. may not cooperate with the test; 9. There are many factors that affect the absorption of oral drugs (such as inability to swallow, nausea and vomiting, chronic diarrhea and intestinal obstruction); 10. After surgical treatment, the disease has progressed further before medication 11. Start to receive adjuvant treatment within 2 months after surgery 12. People infected with HIV; 13. Original serious heart disease, including congestive heart failure, uncontrollable high-risk arrhythmia, unstable angina pectoris, myocardial infarction, severe valvular disease, intractable hypertension, or interstitial lung disease; 14. Irreparable electrolyte abnormalities (sodium, potassium, calcium, magnesium, phosphorus), or long QT interval syndrome history, with an average QTcF = 450 msec (QTcF=QT/RR 0.33); 15. History of retinal vein occlusion; 16. Pregnant or lactating women; 17. It is known to have a history of severe allergy to any monoclonal antibody and BRAF/MEK targeted drugs; 18. Participating in other clinical trials at the same time 19. Other patients who are considered unsuitable for inclusion by the attending physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Relapse-free survival rate at the 24th month; | — |
Secondary
| Measure | Time frame |
|---|---|
| Relapse-free survival rate at the third month;Relapse-free survival rate at the 6th month;Relapse-free survival rate at the 12th month;Relapse-free survival rate at the 18th month;Distant metastasis-free survival;Overall survival;Local or regional-relapse free survival;Relapse-free survival;Disease specific survival;Safety; | — |
Countries
China
Contacts
Public ContactXianqun Fan
Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
Outcome results
None listed