1. Mitomycin C or nitroso urea within ≤ 6 weeks immediately prior to C1D1; anticancer drugs, chemotherapy, radiation or immunotherapy within ≤ 4 weeks immediately prior to C1D1, or have not recovered from the prior anticancer therapy that was received 4 weeks ago (Anticancer drug therapy is defined as any drug or drug combination that have demonstrated anticancer activities, and the purpose of application is to directly or indirectly influence cancer. Patients who have ever received the following therapies can be enrolled: adjuvant chemotherapy, chemotherapy, immunotherapy or steroid therapy for metastatic diseases)