The Safety,Efficacy of Anti-EGFR Humanized Monoclonal Antibody Combined With Chemotherapy in Advanced Solid Tumors.
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Advanced Solid Tumors
- Type
- Interventional
- Phase
- Phase 1Phase 2
- Design
- Allocation: Non-RandomizedIntervention Model: Sequential AssignmentIntervention Model Description: The study used the Bayes optimal interval design (BOIN) to assign the subject's dose level and determine the maximum tolerated dose (MTD) of HLX07 in combination with chemotherapy.Each cohort contains 3 subjects and the patient in the first cohort receives treatment at the lowest dose level (single dose of 400 mg). The decision to increase or decrease the dose after each train is based on the probability of a predefined safety and toxicity threshold. When the observed rate of dose limiting toxicity (DLT) is less than 0.237 (low target safety margin), the dose for the next cohort escalates; when the observed rate of DLT is higher than 0.359 (target high toxicity cutoff), the dose deescalates. Otherwise, the dose remains the same. After each cohort is finished, a safety review committee will be held to determine the escalates or deescalates in the next cohort. The enrollment continues until the maximum 30 patients are reached.Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 75 years
- Gender
- Both males and females
Description
This study is a parallel 3-arm escalation trial with 3 doses of HLX07 (400 mg, 600 mg, or 800 mg per single dose) combined with 3 different fixed-dose chemotherapy regimens. Three chemotherapy regimens are? ? Gemcitabine (1000 mg/m2) and Cisplatin (75 mg/m2) , every three weeks. Gemcitabine was admi...
This study is a parallel 3-arm escalation trial with 3 doses of HLX07 (400 mg, 600 mg, or 800 mg per single dose) combined with 3 different fixed-dose chemotherapy regimens. Three chemotherapy regimens are? ? Gemcitabine (1000 mg/m2) and Cisplatin (75 mg/m2) , every three weeks. Gemcitabine was administered on the first day and on the 8th day, and cisplatin 75 mg/m2 was administered on the first day , a total of 4-6 cycles? ? Paclitaxel (80 mg/m2) and carboplatin (AUC=2), every 3 weeks. Paclitaxel and carboplatin were administered on days 1, 8 and 15 for a total of 4-6 cycles. ? mFOLFOX6 protocol: oxaliplatin (85 mg/m2), leucovorin (400 mg/m2), and 5-fluouracil (5-FU) (400 mg/m2, followed by 2400 mg/m2), every 2 weeks. Oxaliplatin, leucovorin and 5-FU were administered on the first day. After 4 to 6 cycles of (gemcitabine and cisplatin regimens) and (the paclitaxel and carboplatin regimens) or after 6 to 12 cycles of the mFOLFOX6 regimen, well-controlled patients will be continue to receive a weekly HLX07 infusion as maintenance therapy for maximum 2 years or until disease progression or emergence of intolerable toxicity or permanent withdrawal or death (whichever comes first). The study used the Bayes optimal interval design (BOIN) to determine the MTD of HLX07 in combination with chemotherapy.
Tracking Information
- NCT #
- NCT03577704
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Jin E Li, PhD No.1800 Yuntai Road,Pudong District,Shanghai
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