Clinical trial · Interventional
Pegliposomal Doxorubicin and 5-fluorouracil as Second Line Therapy for Metastatic Gastric Cancer
Phase II Study of Pegliposomal Doxorubicin and 5-fluorouracil Compared With Irinotecan as Second Line Therapy for Metastatic Gastric Cancer.
- 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)
For second-line chemotherapy for metastatic gastric cancer, single-agent irinotecan is the standard treatment. Anthracyclines are active but lack well designed investigations. The combination of epirubicin, fluorouracil and cisplatin (or oxaliplatin) are widely used in Europe. However, traditional anthracyclines are more cardiotoxic; and (Pegliposomal Doxorubicin) PLD, as a new liposome dosage form of doxorubicin, has better cardiac safety. Therefore, we designed this phase II trial with PLD and 5-Fu to compare irinotecan monotherapy in the second-line treatment.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5fluorouracil | Drug | — | UNRESOLVED |
| DOXOrubicin Liposome Injection | Drug | — | UNRESOLVED |
| Irinotecan | Drug | Irinotecan | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Irinotecan alone
- description
- 150 mg/m2 iv drip d1; Repeat every 14 days.
- interventionNames
- Drug: Irinotecan
- type
- EXPERIMENTAL
- label
- Pegliposomal Doxorubicin and 5-FU
- description
- Pegliposomal Doxorubicin: 25mg/m2 iv drip d1; 5FU 400mg/m2 iv bolus and 2400 mg/m2 civ 46h d1; Repeat every 14 days.
- interventionNames
- Drug: DOXOrubicin Liposome Injection
- Drug: 5fluorouracil
Primary outcomes (1)
- measure
- Disease control rate (DCR)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age 18-70 years old; 2. Metastatic gastric cancer progressed on first-line treatment; 3. Expected survival time ≥ 3 months; 4. At least one evaluable target lesion according to the solid tumor evaluation criteria (RECIST) version 1.1; 5. ECOG PS 0\~2; 6. Adequate bone marrow function reserve: white blood cell count ≥ 3.0 × 10\*9 / L, neutrophil count ≥ 1.5 × 10\*9/ L; platelet count ≥ 100 ×10\*9/ L; hemoglobin ≥ 90 g / L; 7. Adequate liver and renal function reserve: AST and ALT ≤ 2.5 times the upper limit of normal value, total bilirubin ≤ 2 times the upper limit of normal value; serum creatinine ≤ 1.5 times the upper limit of normal value; 8. LVEF ≥ 55 %; 9. Be able to understand the research process, volunteer to participate in the study, and sign an informed consent form. Exclusion Criteria: 1. Patients known to be allergic to active or other components of chemotherapeutic drugs; 2. Patients who have been treated with PLD or irinotecan in the past; 3. According to the researcher's judgment, other anti-tumor treatments such as radiotherapy and surgical resection are required during chemotherapy; 4. Those who are not expected to be able to tolerate chemotherapy with severe heart disease or discomfort; 5. d-MMR or MSI-H or Her-2 overexpression; 6. Severe or uncontrolled infections or diabetes; 7. History of other malignacis in the past 5 years (except for cured cervical carcinoma in situ or basal cell carcinoma of the skin); 8. Participated in other clinical trials within 4 weeks prior to the start of the study; 9. Pregnant or lactating women, or women of childbearing age who refuse to take effective contraception during the study.
References
Publications (0)
Data not yet available