Nimotuzumab Combined With Paclitaxel for Recurrent Metastatic Gastric or Esophagogastric Junction Adenocarcinoma
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorBiotech Pharmaceutical Co., Ltd.
About this trial
In order to evaluate the efficacy and safety of nimotuzumab combined with paclitaxel as second-line treatment for recurrent metastatic gastric or esophagogastric junction adenocarcinoma with EGFR over-expression, investigators performed a randomized, double-blind, placebo-controlled phase III clinical trial. Patients will be randomized (1:1) to receive nimotuzumab plus paclitaxel in the experimental group and placebo plus paclitaxel in the control group. The primary endpoint of this study was OS, and according to the results of the RAINBOW-Asia gastric cancer phase III clinical study, the mOS of paclitaxel single-agent second-line treatment for gastric cancer was 7.92 months, assuming that the mOS increased to 10.92 months after the addition of nimotuzumab, Using the survival module in the PASS15 software, the two-sided test level was set α=0.05, β=0.20, enrolled for 2 years, followed up for 1.5 years, the dropout rate was 5%, the sample size including interim analysis was 354 cases. The secondary endpoints are progression-free survival (PFS), objective response rate (ORR), duration of response (DOR), disease control rate (DCR), patient reported outcome (PRO), and safety.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
1. Age: 18-75 years old (including boundary value), male or female;
2. The physical status score ECOG is 0-1;
3. Histopathologically or cytologically confirmed gastric or esophagogastric junction adenocarcinoma;
4. Recurrent metastatic disease, previous treatment with first-line standard chemotherapy regimens (including platinum-containing and/or fluorouracil regimens) (recurrence or metastasis during adjuvant therapy or within 6 months after completion is considered first-line therapy), or received anti-HER2 therapy, or received immunotherapy, and has been confirmed by the investigator or has a clear disease progression in the medical history;
Disqualifiers
The disease has progressed after previous paclitaxel chemotherapy or molecular targeted drug (anti-EGFR antibody) treatment, or received paclitaxel chemotherapy or molecular targeted drug (anti-EGFR antibody) treatment within 4 weeks before randomization;
Within 4 weeks before randomization or participating in other therapeutic/intervention clinical trials or receiving combined treatment prohibited by the protocol;
2. Received major surgical treatment, incision biopsy (such as laparotomy) or obvious traumatic injury within 4 weeks before randomization;
3. Brain metastases or meningeal metastases;
Trial design
Design model
Parallel
Treatments tested in this trial
nimotuzumab plus paclitaxel
DrugNimotuzumab injection: 50mg/10ml/stick Paclitaxel: 30mg/5ml/stick
placebo plus paclitaxel
Drugplacebo: 50mg/10ml/stick Paclitaxel: 30mg/5ml/stick
Treatment groups
354 Participants
are divided into 2 treatment groupsGroup A: nimotuzumabExperimental treatment 1 intervention
Group B: placeboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Overall survival
The time between the date of randomization and death from any cause .
Time frame
through study completion, an average of 18 monthsSecondary outcomes
1
progression-free survival
The time between the date of randomization and the date of PD or death when PD was first recorded, whichever occurs first
Time frame
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months2
objective response rate
The optimal total response (BOR) is the incidence of complete response (CR) or partial response (PR).
Time frame
Assessment is performed every 4 weeks for the first 3 months, every 8 weeks to 12 months thereafter, and every 3 months thereafter until disease progression ,assessed up to 12 months3
DCR
CR+PR+SD
Time frame
Assessment is performed every 4 weeks for the first 3 months, every 8 weeks to 12 months thereafter, and every 3 months thereafter until disease progression,assessed up to 12 monthsSponsors and contacts
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Source ClinicalTrials.gov