Clinical trial · Interventional
Study of Apatinib and MASCT in Patients With Advanced Solid Tumors
Phase I/IIa, Single-Arm, Open Study of Apatinib and MASCT in Patients With Advanced Solid Tumors
NCT02844881CI-TRIAL-00023466unknownPhase 1 / Phase 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)
The study is aimed to evaluate the efficacy and safety of Apatinib and MASCT in patients with advanced solid tumors.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
| Excluding T Cell Lymphoma | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Apatinib | Drug | — | UNRESOLVED |
| MASCT | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Apatinib+MASCT
- description
- Apatinib+Multiple Antigens Specific Cellular Therapy(MASCT) in patients with advanced solid tumors,excluding T cell lymphoma
- interventionNames
- Drug: Apatinib
- Biological: MASCT
Primary outcomes (1)
- measure
- Incidence of treatment-related adverse events
- timeFrame
- up to 2 years
- description
- The incidence of treatment-related adverse events were graded with the use of the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0.
Secondary outcomes (4)
- measure
- Progression-Free Survival (PFS)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.