---
title: Concurrent Chemoradiation With or Without DC-CIK Immunotherapy in Treating Locally Advanced Esophageal Cancer
nct_id: NCT01691625
overall_status: COMPLETED
phase: NA
sponsor: Capital Medical University
study_type: INTERVENTIONAL
primary_condition: Esophageal Carcinoma
countries: China
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01691625.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01691625"
ct_last_update_post_date: 2024-02-07
last_seen_at: "2026-05-12T06:01:12.485Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Concurrent Chemoradiation With or Without DC-CIK Immunotherapy in Treating Locally Advanced Esophageal Cancer

**NCT ID:** [NCT01691625](https://clinicaltrials.gov/study/NCT01691625)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 50
- **Lead Sponsor:** Capital Medical University
- **Conditions:** Esophageal Carcinoma
- **Start Date:** 2012-09
- **Completion Date:** 2021-12
- **CT.gov Last Update:** 2024-02-07

## Brief Summary

The purpose of this study is to show if the adoptive cellular therapy with autologous dendritic cells and cytokine-induced killer cells (CIK) combined with concurrent chemoradiation could improve the quality of life of the patients with locally advanced esophageal cancer, compared with concurrent chemoradiation only.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* cytologically or histologically confirmed locally advanced esophageal carcinoma
* Age: \> 18
* Karnofsky performance status ≥ 70
* At least one measurable tumor lesions according to the RECIST criteria.
* Normal functions of heart, lung, liver, kidney and bone marrow
* Blood exams qualified for chemotherapy, which included hemoglobulin ≥9 g/dl, neutrophil ≥1.5×109/L and platelet (PLT) ≥100×109/L, creatinine ≤1.5 UNL
* Informed consent signed

Exclusion Criteria:

* Patients with metastatic disease in the central nervous system (CNS).
* Patients who are pregnant or nursing.
* Patients with poor bone marrow, liver and kidney functions, which would make chemotherapy intolerable
* Patients with contraindication for irradiation: complete obstruction of esophagus, deep esophageal ulcer, fistula to mediastinum, or haematemesis
* coexisted morbidities that investigators believed not suitable for chemoradiation
```

## Arms

- **concurrent chemoradiotherapy plus DC-CIK immunotherapy** (EXPERIMENTAL) — patients will receive concurrent chemoradiotherapy plur DC-CIK immunotherapy
- **Concurrent chemoradiation only** (ACTIVE_COMPARATOR) — patients will receive concurrent chemoradiotherapy only

## Interventions

- **concurrent chemoradiotherapy plus DC-CIK immunotherapy** (OTHER) — Radiotherapy:Patients will be conducted CT simulation, and three-dimensional conformal radiation therapy (3DCRT) or Intensity-modulated radiation therapy(IMRT)was performed. 1.8-2.0 Gy/fraction, 5 fractions a week, with a total dose of 60-66Gy will be delivered for all patients by 6-MV-X-ray of linear accelerator.

Chemotherapy: Patients will be concurrently administered with irradiation every 4 weeks with PT regimen (cis-platinum of 20 mg/m2/d, d2-5; PTX(paclitaxel)of 80mg/m2/d, d1,d8) for 4 cycles.The chemotherapy will be concurrently given with irradiation.

DC-CIK Immunotherapy:Mononuclear cells were collected aseptically with blood cell separator composition apheresis 3 days before concurrent chemoradiation, and cultured DC-CIK cells for 10 days. Cells were infused back to the patients in 3 times between the Chemoradiation intermittent period.
- **Concurrent chemoradiation only** (OTHER) — Radiotherapy:Patients will be conducted CT simulation, and three-dimensional conformal radiation therapy (3DCRT) or Intensity-modulated radiation therapy(IMRT)was performed. 1.8-2.0 Gy/fraction, 5 fractions a week, with a total dose of 60-66Gy will be delivered for all patients by 6-MV-X-ray of linear accelerator.

Chemotherapy: Patients will be concurrently administered with irradiation every 4 weeks with PT regimen (cis-platinum of 20 mg/m2/d, d2-5; PTX(paclitaxel)of 80mg/m2/d, d1,d8) for 4 cycles.The chemotherapy will be concurrently given with irradiation.

## Primary Outcomes

- **the quality of life** _(time frame: initial assessment, months 1, 3, 6 and 12)_

## Secondary Outcomes

- **progression-free survival** _(time frame: 1 year)_

## Locations (1)

- Capital Medical University Cancer Center, Beijing, Beijing Municipality, China

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.capital medical university cancer center|beijing|beijing municipality|china` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT01691625.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT01691625*  
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