Endostar Combined With Paclitaxel and Nedaplatin in Treating Patients With Recurrent or Metastatic Esophageal Cancer

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This phase Ⅱ study was designed to evaluate the efficacy and safety of endostar combined with paclitaxel and nedaplatin as first-line therapy in treating patients with recurrent or metastatic esophageal squamous cell cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yuhong Li
• Treatments: Albumin-Bound Paclitaxel; Endostar protein; Endostatins; Nedaplatin; Paclitaxel

Criteria

Inclusion Criteria:

• Patients have provided a signed Informed Consent Form

• Age: 18-75 years old

• Histologically confirmed diagnosis of recurrent or metastatic or unresectable advanced esophageal squamous cell carcinoma

• Patients have neither received any palliative chemotherapy nor adjuvant chemotherapy or concurrent chemotherapy with taxane based drugs or large doses cisplatin (cumulative dose ≥ 300mg/m2). The time from the last adjuvant or concurrent chemotherapy to relapse or metastasis should more than 6 months.

• Measurable disease in at least 1 diameter by CT scan or MRI as per RECIST 1.1 criteria; Targeted lesions should not include primary esophageal lesions

• Life expectancy ≥ 3 months

• Karnofsky score ≥70

• Patient has adequate bone marrow and organ function

• Leukocyte ≥ 3.5 x 10^9/L

• eAbsolute Neutrophil Count (ANC) ≥ 1.8 x 10^9/L

• Platelets ≥ 90 x 10^9/L

• Hemoglobin ≥ 10g/L

• Patient has adequate liver function

• AST and ALT not more than 2.5 times ULN (not more than 5.0 times ULN if there is liver metastasis)

• Serum bilirubin ≤ 1.2 x ULN

• Creatinine ≤ 1.2 times ULN

• Alkaline phosphatase ≤ 5.0 times ULN

• No serious complications such as active gastrointestinal hemorrhage, perforation, jaundice, gastrointestinal obstruction, non cancerous fever > 38 ℃.

• Patients with effective contraceptive measures

• Expect good compliance

Exclusion Criteria:

• Patients have received radiotherapy in 3 months.

• Patients with relapse recurrent or metastatic lesions in radiated area.

• Patient has received previous treatment with VEGF inhibitors

• Known severe hypersensitivity to the drugs in the experimental chemotherapy or any of the excipients of these products

• Patients without measureable lesions

• Severe systemic disease out of control such as unstable or uncompensated respiratory,cardiac,liver,renal diseases

• Patients with chronic diarrhea

• Patient has a concurrent malignancy or has a malignancy within 5 years of study enrollment (with the exception of nonmelanoma skin cancer or cervical carcinoma in situ

• psychiatric illness including CNS metastases that would prevent the patient from giving informed consent

• Pregnant or lactating women