NCT03047525

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

Status unknown Phase 1, PHASE2 Last updated 9 February 2017

What this trial tests

Phase 1, PHASE2 trial testing Cytokine-induced Killer Cells in Colorectal Cancer in 200 participants. Status unknown.

Timeline

20 February 2017

Primary endpoint
1 January 2019

1 December 2020

Quick facts

Lead sponsor	Xiaoyi Huang
Phase	Phase 1, PHASE2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	200
Start date	20 February 2017
Primary completion	1 January 2019
Estimated completion	1 December 2020
Sites	1 location across China

Drugs / interventions tested

• Cytokine-induced Killer Cells — full drug profile →

Conditions studied

• Colorectal Cancer — all drugs for Colorectal Cancer →
• Renal Cell Carcinoma — all drugs for Renal Cell Carcinoma →
• Nasopharyngeal Carcinoma — all drugs for Nasopharyngeal Carcinoma →
• Lung Cancer — all drugs for Lung Cancer →

Sponsor

Xiaoyi Huang

Who can join

Adults 18 to 75, any sex, with Colorectal Cancer or Renal Cell Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Background: Combinations of Dendritic and Cytokine-induced Killer Cells (DC-CIK) and Cytokine-induced Killer Cells (CIK) treatment may enhance the immune response and stop cancer cells from growing. The investigators suppose that DC-CIK combined with CIK treatment will improve the prognosis of advanced solid tumors.

Objective: Phase II clinical trial to investigate the efficacy of concurrent chemotherapy with DC-CIK and CIK treatment in patients with treatment-refractory solid tumors.

Study treatment:

Patients in group A will receive 4 cycles of CIK treatments and 4 cycles of DC-CIK treatments within 8 months. Patients in group B will have no immunotherapy . chemotherapy are available in both groups.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Influence of the Tumor Microenvironment on NK Cell Function in Solid Tumors.
   Melaiu O, Lucarini V, Cifaldi L, Fruci D. · · 2019 · cited 324× · PMID 32038612 · DOI 10.3389/fimmu.2019.03038
2. Trial watch: dendritic cell vaccination for cancer immunotherapy.
   Sprooten J, Ceusters J, Coosemans A, Agostinis P, et al · · 2019 · cited 107× · PMID 31646087 · DOI 10.1080/2162402x.2019.1638212
3. Trial watch: Dendritic cell (DC)-based immunotherapy for cancer.
   Laureano RS, Sprooten J, Vanmeerbeerk I, Borras DM, et al · · 2022 · cited 101× · PMID 35800158 · DOI 10.1080/2162402x.2022.2096363
4. Harnessing the innate immune system and local immunological microenvironment to treat colorectal cancer.
   Kather JN, Halama N. · · 2019 · cited 63× · PMID 30936499 · DOI 10.1038/s41416-019-0441-6
5. Dendritic Cell-Based Immunotherapy in Lung Cancer.
   Stevens D, Ingels J, Van Lint S, Vandekerckhove B, et al · · 2020 · cited 55× · PMID 33679709 · DOI 10.3389/fimmu.2020.620374
6. Trial Watch: Adoptively transferred cells for anticancer immunotherapy.
   Fournier C, Martin F, Zitvogel L, Kroemer G, et al · · 2017 · cited 55× · PMID 29147628 · DOI 10.1080/2162402x.2017.1363139
7. Immunotherapy in colorectal cancer: for the select few or all?
   Arora SP, Mahalingam D. · · 2018 · cited 48× · PMID 29564183 · DOI 10.21037/jgo.2017.06.10
8. Advances in pathogenesis and precision medicine for nasopharyngeal carcinoma.
   Zhu QY, Zhao GX, Li Y, Talakatta G, et al · · 2021 · cited 41× · PMID 34766141 · DOI 10.1002/mco2.32