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

NCT ID: NCT04214717

Last Updated: 2023-03-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-31

Study Completion Date

2024-12-31

Brief Summary

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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

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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.

Conditions

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Solid Tumor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Combination of DC-CIK with chemotherapy group

Patients will receive DC-CIK treatments combined with Chemotherapy .

Group Type EXPERIMENTAL

DC-CIK combined with Chemotherapy

Intervention Type COMBINATION_PRODUCT

Patients will receive 4 cycles of DC-CIK treatments combined with Chemotherapy within 8 months.

Chemotherapy group

Patients will only receive Chemotherapy.

Group Type ACTIVE_COMPARATOR

Chemotherapy

Intervention Type DRUG

Patients will only receive Chemotherapy.

Interventions

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DC-CIK combined with Chemotherapy

Patients will receive 4 cycles of DC-CIK treatments combined with Chemotherapy within 8 months.

Intervention Type COMBINATION_PRODUCT

Chemotherapy

Patients will only receive Chemotherapy.

Intervention Type DRUG

Eligibility Criteria

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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.

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.)
Minimum Eligible Age

10 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yantai Yuhuangding Hospital

OTHER

Sponsor Role lead

Responsible Party

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Peiwen Lian

Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Peiwen Lian, PhD

Role: STUDY_DIRECTOR

Yantai Yuhuangding Hospital

Locations

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Yantai Yuhuangding Hospital

Yantai, Shandong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Peiwen Lian, PhD

Role: CONTACT

+0086 5356691999 ext. 82708

Jian Chen, PhD

Role: CONTACT

+0086 5356691999 ext. 81511

Facility Contacts

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Peiwen Lian, PhD

Role: primary

+0086 5356691999 ext. 82708

Other Identifiers

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2019-008

Identifier Type: -

Identifier Source: org_study_id

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