Clinical trial · Interventional
Infusional Fluorouracil and Weekly Docetaxel for Gastric Cancer With Bone Marrow Involvement and DIC
Infusional Fluorouracil and Weekly Docetaxel as First-line Therapy for Gastric Cancer With Bone Marrow Metastasis and Disseminated Intravascular Coagulation: a Multi-center, Phase II Trail
NCT04547153CI-TRIAL-00075369completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A distinctive subtype of gastric adenocarcinoma with extensive bone marrow metastasis and DIC has been described. Few patients have been treated properly due to the lack of standard care. We designed this phase II study to evaluate a dose-dense regimen for this kind of highly aggressive gastric cancer (HAGC).
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bone Marrow Metastasis | — | UNRESOLVED | — |
| Disseminated Intravascular Coagulation | — | UNRESOLVED | — |
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-fluorouracil | Drug | Fluorouracil | ALIAS |
| Docetaxel | Drug | Docetaxel | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- LD-FUD (Zhen Long)
- description
- 5-fluorouracil 200mg/square metre/day continuously venous infusion on days 1-21; Docetaxel 25mg/square metre, on days 1, 8 and 15; This regimen repeats every 4 weeks.
- interventionNames
- Drug: 5-fluorouracil
- Drug: Docetaxel
Primary outcomes (1)
- measure
- hematological response rate (HeRR)
- timeFrame
- 2 months
- description
- percentage of participants whose platelet restored to normal range
Secondary outcomes (5)
- measure
- time to hematological response (TTHeR)
- timeFrame
- 2 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * ECOG PS 0-3; * Pathologically confirmed adenocarcinoma in stomach or esophagogastric junction; * Bone marrow metastasis confirmed by aspiration, biopsy or PET/CT scan; * overt DIC according to the International Society on Thrombosis and Haemostasis (ISTH) criteria; * Treatment-naive after the diagnosis of metastasis; * Platelet ≤ 50 \* 10E9/L; * ALT≤5×ULN, AST≤5×ULN, Bilirubin≤5×ULN, Creatinine≤3×ULN; * Written informed consent. Exclusion Criteria: * Concurrent aggressive malignancy; * Docetaxel containing perioperative treatment within 6 months; * Allergic to the study drugs; * Serious medical conditions, including severe heart disease, severe cerebrovascular disease, uncontrolled diabetes, uncontrolled hypertension, uncontrolled infection,etc. * HIV positive; * MSI-H; * Her-2 gene overexpression; * Inadequate contraceptive measures.
References
Publications (3)
- BACKGROUNDMorita R, Ishikawa T, Sawai Y, Kajiwara M, Asaeda K, Kobayashi R, Miyazaki H, Doi T, Inoue K, Dohi O, Yoshida N, Kamada K, Uchiyama K, Takagi T, Konishi H, Naito Y, Itoh Y. [A Long-Term Survival Case of Gastric Cancer with Disseminated Intravascular Coagulation due to Myelocarcinomatosis Treated with S-1 plus Oxaliplatin Therapy]. Gan To Kagaku Ryoho. 2021 May;48(5):731-734. Japanese. PMID 34006725
- BACKGROUNDKwon JY, Yun J, Kim HJ, Kim KH, Kim SH, Lee SC, Kim HJ, Bae SB, Kim CK, Lee NS, Lee KT, Park SK, Won JH, Hong DS, Park HS. Clinical outcome of gastric cancer patients with bone marrow metastases. Cancer Res Treat. 2011 Dec;43(4):244-9. doi: 10.4143/crt.2011.43.4.244. Epub 2011 Dec 27. PMID 22247710
- DERIVEDXiaohui Z, Shanshan L, Taiyuan C, Ge D, Hongen Y, Lishuo S, Xiaoru L, Wanjia H, Jian X. Docetaxel and fluorouracil as first-line therapy for gastric cancer with bone marrow metastasis and disseminated intravascular coagulation. Future Oncol. 2022 Nov;18(35):3875-3880. doi: 10.2217/fon-2022-0748. Epub 2022 Nov 8. PMID 36346044