Revisiones para Nimotuzumab Combined With Paclitaxel for Recurrent Metastatic Gastric or Esophagogastric Junction Adenocarcinoma | Registro Público Cubano de Ensayos Clínicos

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Revisión actual:

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

General information

Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.

Acronym of Public Title:

NOTABLE-307

Scientific title:

Nimotuzumab combined with paclitaxel as a second-line treatment for metastatic or recurrent gastric or gastroesophageal junction adenocarcinoma with EGFR overexpression: Phase III, randomized, double-blind, placebo-controlled clinical trial (NOTABLE-307 study)

Acronym of Scientific Title:

NOTABLE-307

Secondary indentifying numbers:

BPL-Nim-GC-3001

NCT05978050

Issuing authority of the secondary identifying numbers:

Biotech Pharmaceutical Co., Ltd.

ClinicalTrials.gov

Source(s) of monetary or material support:

Biotech Pharmaceutical Co., Ltd. (China), Center of Molecular Immunology (CIM, Cuba), Cuban Ministry of Public Health (MINSAP, Cuba)

Authorization for beginning

Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.

Regulatory instance to authorize the initiation of the study:

Center for State Control of Drugs, Medical Devices and Equipment (CECMED)

Reference number:

In process

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

Rui-hua

Last name:

Xu

Medical Specialty :

Oncologist

Affiliation:

Sun Yat-sen University Cancer Center

Postal address:

No. 651, Dongfeng East Road, Gunagzhou City, Guangdong Province

City:

Guangzhou City

País:

China

Zip Code:

510000

Telephone:

+53-02087343333

Email address:

xurh@sysucc.org.cn

Clinical sites to participate

Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.

Countries of recruitment:

China

Cuba

Clinical sites:

Havana, Hermanos Ameijeiras Surgical Clinical Hospital, Vilma Fleites Calvo, MD. Specialist of first degree in Oncology

Villa Clara, Celestino Hernandez Robau University Hospital, Ana Victoria de la Torre PhD. Specialist of second degree in Oncology

Havana, Center for Medical-Surgical Research (CIMEQ), Josue de la Torre Pupo, MD. Specialist of second degree in Oncology

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Recruiting

Date of first enrollment:

18/05/2024

Health condition and Intervention

Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).

Health condition(s) or Problem(s) studied:

Gastric and gastroesophageal junction adenocarcinoma

Health condition(s) code:

Adenocarcinoma

Stomach Neoplasms

Gastrointestinal Neoplasms

Esophageal Neoplasms

Neoplasms of the Digestive System

Stomach Diseases

Gastrointestinal Diseases

Esophageal Diseases

Digestive System Diseases

Health condition keyword:

-

Intervention(s):

Group Nimotuzumab plus Paclitaxel (Experimental): Patients will receive nimotuzumab injection, by intravenous route, 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, by intravenous route, 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 Group Placebo plus Paclitaxel (Control): Patients will receive placebo, by intravenous route, 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, by intravenous route, 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.

Intervention code:

Antibodies, Monoclonal, Humanized

Antibodies, Monoclonal

Paclitaxel

Placebos

Administration, Intravenous

Intervention keyword:

Nimotuzumab

Outcomes and Timepoint

Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.

Primary outcome(s):

Overall survival (Time from randomization until death from any cause). Measurement time: Through study completion, an average of 18 months

Key secondary outcomes:

1. Progression-free survival (Time from randomization to the date of first documented progression or date of death from any cause, whichever occurs first). Measurement time: Up to 12 months. 2. Objective response rate (Incidence of complete response (CR) or partial response (PR)). Measurement time: Every 4 weeks for the first 3 months, every 8 weeks until 12 months thereafter, and every 3 months thereafter until disease progression, assessed up to 12 months. 3. Duration of response (Time from the first assessment of CR or PR, whichever is documented first, to the first day of radiographic disease progression, as defined in RECIST version 1.1, or death from any cause, whichever occurs first). Measurement time: Every 4 weeks for the first 3 months, every 8 weeks until 12 months later, and every 3 months thereafter until disease progression, evaluated up to 12 months. 4. Disease Control Rate (Incidence of Complete response (CR) or Partial response (PR) or Stable disease (SD)). Measurement time: Every 4 weeks for the first 3 months, every 8 weeks until 12 months later, and every 3 months thereafter until disease progression, evaluated up to 12 months.

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Male/Female

Minimum age:

18 years

Maximum age:

75 years

Inclusion criteria:

1. Age: 18-75 years (including the limit values), male or female; 2. ECOG performance status score 0-1; 3. Gastric adenocarcinoma or esophagogastric junction adenocarcinoma confirmed by histology or cytology; 4. Metastatic or recurrent disease, previously treated with standard first-line chemotherapy regimens (including platinum-containing and/or fluoropyrimidine-containing regimens) (recurrence or metastasis during adjuvant therapy or within 6 months after completion will be considered first-line treatment), or who received targeted therapy, or received immunotherapy, with disease progression confirmed by the investigator or in the medical history; 5. According to RECIST 1.1 evaluation criteria, there must be at least one measurable lesion; 6. High EGFR expression (IHC2 or IHC3) detected during the recruitment period in primary or metastatic lesion tissue (when multiple samples are available at the same time, the preference will be: the complete specimen instead of a biopsy sample, and metastatic tissue instead of the primary lesion); 7. Estimated survival ≥12 weeks; 8. Adequate organ function, defined as: Total bilirubin ≤ 1.5 times the upper limit of normal (ULN); alanine aminotransferase (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 ≤ 1.5 times ULN; neutrophil count ≥1.5×10^9/L; white blood cell count ≥ 3.0×10^9/L; platelets ≥ 100×10^9/L; hemoglobin ≥ 90 g/L; 9. If the patient is of childbearing potential, both the patient and their partner must be willing to use contraception; 10. Negative pregnancy test in women of potential fertility/negative serum hCG within 72 hours prior to randomization (postmenopausal women with at least 12 months of amenorrhea are considered infertile, and women known to have undergone tubal ligation are not required to have a pregnancy test); 11. The subject understands and agrees with the study procedures, decides to participate voluntarily, and signs the informed consent form.

Exclusion criteria:

1. Prior treatment received before study initiation: a. Disease progression following prior paclitaxel chemotherapy or anti-EGFR antibody therapy; or administration of paclitaxel chemotherapy or anti-EGFR antibody treatment within 4 weeks prior to randomization. b. Participation in another therapeutic/interventional clinical trial (counted from the last administration of first-line treatment), or receipt of prohibited concomitant therapies specified in the study protocol within 4 weeks prior to randomization or at screening. 2. Major surgical procedure, incisional biopsy (e.g., laparotomy), or significant traumatic injury within 4 weeks prior to randomization. 3. Presence of brain metastases or leptomeningeal metastases. 4. History of malignant tumors other than gastric adenocarcinoma or gastroesophageal junction adenocarcinoma (exceptions: cured cervical carcinoma in situ, cutaneous basal cell carcinoma, or other malignancies cured for at least 5 years). 5. Severe hemorrhagic disorders (e.g., severe gastrointestinal bleeding) or vasculitis occurring within 3 months prior to randomization. 6. Presence of other severe illnesses, including but not limited to: a. Refractory congestive heart failure (NYHA Class III or IV, see Appendix 2), unstable angina, poorly controlled arrhythmias, uncontrolled moderate to severe hypertension (systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg); b. Uncontrolled diabetes mellitus; c. Psychiatric disorders impairing the ability to provide informed consent and/or protocol compliance; d. Other severe medical conditions rendering the patient ineligible for study participation at the investigator’s discretion. 7. Known allergies or contraindications to any components of anti-EGFR antibody formulations, paclitaxel, or other study medications. 8. Toxicities from prior anti-tumor therapy that have not resolved to Grade ≤1 per CTCAE v5.0, with the following allowable exceptions: a. Alopecia; b. Other toxicities deemed clinically insignificant by the investigator (e.g., stable Grade 2 fatigue, hyperpigmentation). 9. History of clinically significant third-space fluid accumulation (including large-volume pleural effusion or ascites) unmanageable with drainage or other interventions. 10. Pre-existing Grade 2–4 peripheral neuropathy per CTCAE criteria. 11. Known past or current active primary or secondary immunodeficiency. 12. Confirmed positive HIV serology or syphilis infection. For patients with positive Treponema pallidum antibodies, a non-treponemal syphilis serology test (RPR or TRUST) will be performed; the investigator will also review clinical history and prior treatment records to confirm latent/inactive syphilis. Active hepatitis B or C infection at screening is also exclusionary: • Active hepatitis B: HBsAg positive plus HBV DNA >1000 copies/mL; • Active hepatitis C: Anti-HCV antibody positive plus HCV RNA >1000 copies/mL. 13. Females of childbearing potential who are pregnant, breastfeeding, planning pregnancy, or not using effective contraception. Sexually active male patients who refuse contraceptive measures throughout the study period and for 3 months after the last study drug dose, or intend to donate sperm during this timeframe. 14. Any medical, psychiatric, or other condition deemed by the investigator to pose risks to subject safety or compromise the integrity of study data should the patient enroll in this clinical trial.

Type of population:

Adults

Type of participant:

Patients

Study design

Section to complete information about the characteristics of the study design.

Type study:

Interventional

Purpose:

Treatment

Allocation:

Randomized controlled trial

Masking:

Double Blind

Control group:

Placebo

Study design:

Parallel

Phase:

3

Target sample size:

354

Contact for public queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status

First Name:

Mayra

Last Name:

Ramos Suzarte

Specialty:

Biochemistry. PhD. in Health Sciences

Affiliation:

Center oh Molecular Immunology (CIM)

Postal Address:

216 y 15. Atabey. Playa

City:

Havana

País:

Cuba

Zip Code:

11600

Telephone:

+53-53310380

Email :

mayra@cim.sld.cu

Contact for scientific queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.

First Name:

Mayra

Last Name:

Ramos Suzarte

Specialty:

Biochemistry. PhD. in Health Sciences

Affiliation:

Center of Molecular Immunology (CIM)

Postal Address:

216 y 15. Atabey. Playa

City:

Havana

País:

Cuba

Zip Code:

11600

Telephone:

+53-53310380

Email :

mayra@cim.sld.cu

Research Ethics Committees

Section to complete the data related to the review ethics committees.

Name of Research Ethics Committees:

Hermanos Ameijeiras Surgical Clinical Hospital

Celestino Hernandez Robau University Hospital

Center for Medical-Surgical Research (CIMEQ)

Status of evaluation:

Approved

Status of evaluation date of Ethic Committee:

14/10/2025

30/01/2026

21/05/2026

Postal address of Ethic Committee :

San Lazaro # 701 esq. a Belascoain, Centro Habana, ZC:10400, Havana, Cuba

Cuba No. 564 entre Barcelona y Hospital, Villa Clara, ZC: 50100, Cuba

Calle 216 y 11B, Siboney, Playa. P.O. Box 6096, Havana 6. Havana, Cuba

Telephone:

+53-52833178

+53-56096863

+53-72718424

Correo electrónico:

jorgeluishernandezcastro52@gmail.com

jossylugo347@gmail.com

bcimeq@infomed.sld.cu

About study completion

Section to complete the data related to the study completion.

Study completion date:

08/11/2028

Registration and Update

Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).

Primary registry:

RPCEC

Unique ID number:

RPCEC00000482

Date of Registration in Primary Registry:

24/08/2026

Record Verification Date:

2026/10/01

Next update date:

2027/10/01

Link to the spanish version:

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

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