Study of DC-CIK Combined With Chemotherapy for Advanced Solid Tumor

Not Applicable

Recruiting

• Conditions: Solid Tumor
• Interventions: Combination Product: DC-CIK combined with Chemotherapy; Drug: Chemotherapy

• Registration Number: NCT04214717
• Lead Sponsor: Yantai Yuhuangding Hospital

Brief Summary

Combinations of Dendritic cell-activated cytokine-induced killer cell (DC-CIK) With chemotherapy treatment may enhance the immune response and stop cancer cells from growing.

Detailed Description

Patients in group A will receive 4 cycles of DC-CIK treatments within 8 months. Patients in group B will have no immunotherapy. Chemotherapy are available in both groups.The investigators want to evaluate the efficacy of combination of DC-CIK with chemotherapy in patients with treatment-refractory solid tumors.

Study Timeline

• Study First Submitted: 2019-12-30
• Study First Submitted QC: 2019-12-30
• Study Start: 2019-12-31
• Study First Posted: 2020-01-02
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-26
• Last Update Posted: 2023-03-28
• Primary Completion: 2023-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Patients with treatment-refractory advanced solid cancer can not accept operation;
2. Age 10 to 90 years;
3. Eastern Cooperative Oncology Group (ECOG) score ≤ 2 points;
4. Estimate survival > 3 months;
5. Blood White Blood Cell(WBC)≥ 4×109/L, Hb ≥ 100g/L, Platelet Count (PLT)≥ 80×109/L; Alanine amino transferase (ALT) and aspartate amino transferase (AST)≤ 2 times of normal upper value; Serum Cr ≤ 2 normal upper value;
6. Without any other malignant disease;
7. With more than one scalable lesions;
8. Patients Voluntary attempt, and informed consent;
9. Women of child-bearing potential must have a negative pregnancy test because of the potentially dangerous effects of the preparative chemotherapy on the fetus.

Exclusion Criteria

1. Patients who do not conform to the inclusion criteria;
2. Patients with uncontrolled infection; underlying disease that was severe or life-threatening (such as uncontrolled brain metastasis );
3. Patients who were pregnant or lactating;
4. ECOG perform status ≥ 2;4.
5. Other situations that the researchers considered unsuitable for this study (such as mental illness, drug abuse, etc.)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Combination of DC-CIK with chemotherapy group	DC-CIK combined with Chemotherapy	Patients will receive DC-CIK treatments combined with Chemotherapy .
Chemotherapy group	Chemotherapy	Patients will only receive Chemotherapy.

Primary Outcome Measures

Name	Time	Method
Disease Control Rates (DCR)	1 year	Disease Control Rates (Complete Remission + Partial Remission + Stable Disease), according to solid tumor response evaluation standard (Response evaluation criteria in solid tumors, RECIST).

Trial Locations

Locations (1)

Yantai Yuhuangding Hospital; 🇨🇳 Yantai, Shandong, China