Study of Apatinib and MASCT in Patients With Advanced Solid Tumors

• Status: Unknown status
• Trial end date: 2018-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The study is aimed to evaluate the efficacy and safety of Apatinib and MASCT in patients with advanced solid tumors.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The First People's Hospital of Lianyungang
• Collaborators: Hengrui Yuanzheng Bio-Technology Co., Ltd.; HengRui YuanZheng Bio-Technology Co.,Ltd.
• Treatments: Apatinib

Criteria

Inclusion Criteria:

1. Patients with histologically-confirmed, advanced (unresectable) solid tumors who have progressed on standard therapy.

2. With written informed consent signed voluntarily by patients themselves.

3. The time of between Patients enrollment and the end of other anti-tumors therapies≤1 month

4. Eastern Cooperative Oncology Group Performance Status (ECOG P.S.) of ≤ 2

5. At least one measurable lesion as defined by RECIST criteria 1.1 for solid tumors.

6. Life expectancy ≥6 months.

7. With normal cardiopulmonary function.

8. Patients have adequate organ function as defined by the following criteria:

• Hemoglobin (HGB) ≥85g/L

• Absolute neutrophil count (ANC) ≥1.0×109/L

• White blood cell (WBC) ≥3.0×109/L

• Platelet count ≥50×109/L

• Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) of ≤2.5 upper normal limitation (UNL) or ≤5 UNL in case of liver metastasis

• Alkaline phosphatase (ALP)≤2.5 UNL

• Total bilirubin (TBil) of ≤1.5 UNL

• Blood urea nitrogen (BUN) and Creatinine (Cr) of≤1.5 UNL

• Albumin (ALB) ≥30g/L

Exclusion Criteria:

1. Pregnant or expecting to pregnant

2. Participated in other clinical trials before screening except of observational study.

3. Known allergic history of sodium citrate drugs.

4. Known history of organ transplant, including autologous bone marrow transplantation and peripheral stem cell transplantation.

5. Known active brain metastases as determined by CT or MRI evaluation.

6. The use of immunosuppressive drugs with current or 14 days before enrollment.

7. Know the period of systemic and continuous use of immunomodulatory agents (such as interferon, thymosin, traditional Chinese medicine) within 6 months.

8. Prior therapy with anti-programmed death-1 (anti-PD-1), anti-programmed cell death ligand 1 (anti-PD-L1), or anti-Cytotoxic T lymphocyte-associated antigen 4 (anti-CTLA-4) antibody (including any other antibody or drug specifically targeting T-cell co-stimulation).

9. Known history of primary immunodeficiency diseases.

10. Known history of tuberculosis.

11. Known active human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.

12. Patients with serious infection, hepatopathy, nephropathy, respiratory disease, cardiovascular disease or incontrollable diabetes, etc.

13. Patients have other malignant tumors within 5 years,excluding melanoma and carcinoma in situ of cervix.

14. Treatment with any anti-tumors agent within 28days of first administration of study treatment.