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

NCT ID: NCT04358341

Last Updated: 2020-08-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 136 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-17
• Study Completion Date: 2022-12-01

Brief Summary

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.

Detailed 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.

Conditions

Gastric Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Irinotecan alone

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

Group Type: ACTIVE_COMPARATOR

Irinotecan

Intervention Type: DRUG

150 mg/m2 ivdrip every 14 days

Pegliposomal Doxorubicin and 5-FU

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

Group Type: EXPERIMENTAL

DOXOrubicin Liposome Injection

Intervention Type: DRUG

25 mg/m2 ivdrip every 14 days

5fluorouracil

Intervention Type: DRUG

400mg/m2 iv bolus and 2400 mg/m2 civ 46h every 14 days

Interventions

Irinotecan

150 mg/m2 ivdrip every 14 days

Intervention Type: DRUG

DOXOrubicin Liposome Injection

25 mg/m2 ivdrip every 14 days

Intervention Type: DRUG

5fluorouracil

400mg/m2 iv bolus and 2400 mg/m2 civ 46h every 14 days

Intervention Type: DRUG

Other Intervention Names

CPT-11; Pegliposomal Doxorubicin; 5-FU

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sixth Affiliated Hospital, Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Jian Xiao

Asso. Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jian Xiao, MD

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-sen University

Locations

Jian Xiao

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xiaohui Zhai, MD

Role: CONTACT

zhaixh@mail.sysu.edu.cn

862038285497 ext. 862038285497

Shanshan Li

Role: CONTACT

lishsh89@163.com

862038285497 ext. 862038285497

Facility Contacts

Jian Xiao, MD

Role: primary

xiaoj26@mail.sysu.edu.cn

862038285497 ext. 862038285497

Other Identifiers

SAHMO205

Identifier Type: -

Identifier Source: org_study_id