Multi-center, randomized controlled study on the combination therapy of DC-ALT and FOLFOX4 regimen for Dukes’ C (III) stage of colon carcinoma

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-TRC-08000135

Enrollment

Unknown

Registered

2008-07-31

Start date

2008-03-01

Completion date

Unknown

Last updated

2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colon carcinoma

Interventions

Group A:Operation + chemotherapy of FOLFOX4 for 12 weeks

Group B:Operation + chemotherapy of FOLFOX4 for 12 weeks + DC-ALT for two courses of treatment

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Aged between 18 and 70 years old; with ECOG 0-2; 2. Patients with the diagnosis of Dukes’ C stage of colon carcinoma confirmed by pathological examination and been treated by radical operation; 3. Been treated by chemotherapy based on FOLFOX4 regimen for 6 therapy courses and complete the last chemotherapy before 4 to 6 weeks; no evidence of recurrence or metastasis; 4. Expected life >6 months; able to cooperate for follow-ups of side effects and efficacy; 5. Sign informed content forms.

Exclusion criteria

Exclusion criteria: 1. HIV carriers; or patients with other immunodeficiency diseases or organs transplantation; 2. The use of large dosage of glucocorticoids; 3. Dysfunction of heart, liver, lung, kidney or bone marrow (WBC<3000/mm3); 4. With infections that may influence the observation of effects.

Design outcomes

Primary

Measure	Time frame
Total survival rate;Disease-free Survival, DFS;	—

Secondary

Measure	Time frame
Local recurrence rate;Safety;Metastasis rate;Immunity effectivenes;	—

Countries

China

Contacts

Public ContactDesen Wan

wds@medmail.com.cn+86 020 87343124

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026