Nimotuzumab Combined With Paclitaxel for Recurrent Metastatic Gastric or Esophagogastric Junction Adenocarcinoma

NCT05978050 | Recruiting Phase 3 DMC

• 1 other identifier: BPL-Nim-GC-3001
• Study Type: interventional
• Target: 354
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gastric or Esophagogastric Junction Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• Overall survival

  The time between the date of randomization and death from any cause .

  through study completion, an average of 18 months

Secondary Outcomes (3)

• progression-free survival

  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 months

• objective response rate

  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 months

• DCR

  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 months

Study Arms (2)

nimotuzumab

EXPERIMENTAL

Participants received nimotuzumab injection 600 mg for the first time, followed by 400 mg once a week until disease progression or inability to tolerate or withdrawal from the trial; At the same time, in combination with paclitaxel 80 mg/m2, it was administered on days 1, 8 and 15 of each treatment cycle (4 weeks) until the disease progressed or could not be tolerated or withdrew from the trial.

Drug: nimotuzumab plus paclitaxel

placebo

PLACEBO COMPARATOR

Participants received placebo 600 mg for the first time, followed by 400 mg once a week until disease progression or inability to tolerate or withdrawal from the trial; At the same time, in combination with paclitaxel 80 mg/m2, it was administered on days 1, 8 and 15 of each treatment cycle (4 weeks) until the disease progressed or could not be tolerated or withdrew from the trial.

Drug: placebo plus paclitaxel

Interventions

nimotuzumab plus paclitaxel DRUG

Nimotuzumab injection: 50mg/10ml/stick Paclitaxel: 30mg/5ml/stick

Also known as: Combined with chemotherapy

nimotuzumab

placebo plus paclitaxel DRUG

placebo: 50mg/10ml/stick Paclitaxel: 30mg/5ml/stick

Also known as: chemotherapy alone

placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Age: 18-75 years old (including boundary value), male or female;
• \. The physical status score ECOG is 0-1;
• \. Histopathologically or cytologically confirmed gastric or esophagogastric junction adenocarcinoma;
• \. 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;
• \. At least one evaluable tumor lesion according to the RECIST version 1.1 evaluation criteria;
• \. Detection of primary or metastatic lesions during the screening period (when multiple specimens exist at the same time, the bulk specimen is preferred over the biopsy specimen, and the metastasis is preferred over the primary lesion) tissue is determined to be EGFR high expression (IHC2+ or IHC3+);
• \. Estimated survival≥ 12 weeks;
• \. Have proper organ function, defined as:Total bilirubin ≤ 1.5 times the upper normal limit (ULN); glutamyltransferase (ALT) or aspartate aminotransferase (AST) ≤ 2.5 times ULN in the absence of liver metastases; ALT or AST ≤ 5 times ULN in the presence of liver metastases;Serum creatinine level≤ 1.5 times ULN; neutrophil count ≥1.5×109/L; WBC count≥ 3.0×109/L; platelets≥ 100×109/L; Hemoglobin≥ 90g/L;
• \. Patients of childbearing age and their spouses are willing to use contraception;
• \. Women of potential fertility have negative serum hCG within 72 hours prior to randomization (postmenopausal women with amenorrhea for at least 12 months are considered infertile, and women who are known to have undergone tubal ligation are not required to undergo a pregnancy test);
• \. The subject understands and complies with the study process, voluntarily participates, and signs the informed consent form.

You may not qualify if:

• \. Received the following treatments before this study:
• 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;
• \. Received major surgical treatment, incision biopsy (such as laparotomy) or obvious traumatic injury within 4 weeks before randomization;
• \. Brain metastases or meningeal metastases;
• \. Has a history of malignant tumors other than gastric adenocarcinoma or esophagogastric junction adenocarcinoma (except for cured cervical carcinoma in situ or skin basal cell carcinoma and other malignant tumors that have been cured for 5 years);
• \. Known to have suffered from severe bleeding disorders (such as severe gastrointestinal bleeding) and vasculitis within 3 months before randomization;
• \. Known to be accompanied by other serious diseases, including but not limited to:
• Refractory congestive heart failure (NYHA classification III or IV, see Appendix 2), unstable angina, poorly controlled arrhythmia, uncontrolled moderate or high blood pressure (SBP\>160mmHg or DBP\>100mmHg );
• Uncontrolled diabetes;
• Mental illness that affects informed consent and/or protocol compliance;
• There are serious diseases that other researchers believe are not suitable for participating in this study;
• \. Known allergies or contraindications to anti-EGFR antibody preparations, paclitaxel and other components;
• \. Those who are known to have third space effusion (including a large amount of pleural effusion or ascites) that cannot be controlled by drainage or other methods;
• \. Known NCI CTC grade 2-4 peripheral neuropathy;

Sponsors & Collaborators

• Biotech Pharmaceutical Co., Ltd.: lead

Study Sites (1)

National Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

RECRUITING

MeSH Terms

Interventions

nimotuzumab; Paclitaxel; Drug Therapy

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Therapeutics

Study Officials

• ruihua Xu, Doctor

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

xijuan Song

CONTACT

010-51571020; songxijuan@biotechplc.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2023
• First Posted: August 7, 2023
• Study Start: August 1, 2024
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: August 28, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)