Pegliposomal Doxorubicin and 5-fluorouracil as Second Line Therapy for Metastatic Gastric Cancer

Sun Yat-sen University

Status and phase: Unknown; Phase 2

Conditions: Gastric Cancer

Treatments: Drug: 5fluorouracil; Drug: Irinotecan; Drug: DOXOrubicin Liposome Injection

Study type: Interventional

Funder types: Other

Identifiers

NCT04358341

SAHMO205

Details and patient eligibility

About

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.

Full description

Patients with metastatic gastric cancer failed to first-line therapy will be radomized to arm A with PLD and 5-Fu and arm B with irinotecan single agent therapy. Both regimens will be treated every 2 weeks until disease progression or untolerable toxicity. Efficacy will be assessed every 3 cycles and safety will be evaluated every cycle.

Enrollment: 136 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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136 participants in 2 patient groups

Irinotecan alone

Active Comparator group

Description:

150 mg/m2 iv drip d1; Repeat every 14 days.

Treatment:

Drug: Irinotecan

Pegliposomal Doxorubicin and 5-FU

Experimental group

Description:

Pegliposomal Doxorubicin: 25mg/m2 iv drip d1; 5FU 400mg/m2 iv bolus and 2400 mg/m2 civ 46h d1; Repeat every 14 days.

Treatment:

Drug: DOXOrubicin Liposome Injection

Drug: 5fluorouracil