Gentuximab Combined With Paclitaxel Compared With Placebo Combined With Paclitaxel for Gastric Adenocarcinoma.

NCT05919381 | Unknown Phase 3 DMC

• 1 other identifier: Gensci043-GC-III01
• Study Type: interventional
• Target: 752
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the efficacy and safety of the combination of Gentuximab Injection and Paclitaxel Injection in patients with advanced gastric or gastroesophageal junction adenocarcinoma after first-line treatment failure compared with Placebo and Paclitaxel Injection.

Conditions

Adenocarcinoma of Stomach

Keywords

Adenocarcinoma of stomach or gastroesophageal junction.

Outcome Measures

Primary Outcomes (1)

• OS

  From date of randomization until the date of first documented death from any cause,assessed up to 36 months.

  36 months.

Secondary Outcomes (2)

• PFS

  36 months.

• TTF ORR DCR DOR

  36 months. 36 months. 36 months. 36 months.

Other Outcomes (2)

• Change form baseline in EORTC QLQ-C30.

  36 months.

• Change form baseline in EQ-5D-3L.

  36 months.

Study Arms (2)

Gentuximab Injection

EXPERIMENTAL

Gentuximab Injection 8 mg/kg, D1, 15 intravenous drip, combined with Paclitaxel Injection 80 mg/m2/time, D1, 8, 15 intravenous drip, a cycle every 28 days.

Drug: Gentuximab Injection; Drug: Gentuximab Injection Placebo

Gentuximab Injection Placebo

PLACEBO COMPARATOR

Gentuximab Injection Placebo 8 mg/kg, D1, 15 intravenous drip, combined with Paclitaxel Injection 80 mg/m2/time, D1, 8, 15 intravenous drip, a cycle every 28 days.

Drug: Gentuximab Injection; Drug: Gentuximab Injection Placebo

Interventions

Gentuximab Injection DRUG

Gentuximab Injection 8 mg/kg, D1, 15 intravenous drip, a cycle every 28 days.

Gentuximab Injection; Gentuximab Injection Placebo

Gentuximab Injection Placebo DRUG

Gentuximab Injection Placebo 8 mg/kg, D1, 15 intravenous drip, a cycle every 28 days.

Gentuximab Injection; Gentuximab Injection Placebo

Eligibility Criteria

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

You may qualify if:

• \~75 years old (including boundary value), male and female.
• Patients with advanced gastric cancer or gastroesophageal junction adenocarcinoma diagnosed by histology have developed disease after receiving first-line treatment containing platinum and fluorouracil for at least one cycle.
• It is necessary to make sure that the Her-2 expression status is negative or Her-2 positive and fails to be treated with anti-Her-2 targeted drugs.
• There is at least one measurable focus according to the RECIST 1.1 evaluation criteria for the efficacy of solid tumors.
• The physical condition score of the Eastern Cancer Cooperation Group (ECOG) was 0 or 1.
• The expected life is at least 3 months.
• Weight ≥ 40 kg, or BMI ≥ 17.

You may not qualify if:

• • Have received any systemic treatment targeting VEGF or VEGFR signal pathway.
• Have received systemic treatment of paclitaxel, docetaxel and paclitaxel for injection (albumin binding type).
• Those who are allergic to antibody-like recombinant protein drugs, paclitaxel and its excipients.
• Have received chemotherapy, radiotherapy, molecular targeted therapy, immunotherapy and other systemic anti-tumor treatment within 4 weeks before the first administration or within 5 half-lives of the drug.
• Have undergone major surgery within 4 weeks before the first administration.
• Thromboembolism occurred within 6 months before screening.
• Be receiving anticoagulant treatment with warfarin or similar preparations.
• Severe hemorrhagic disease, vasculitis or gastrointestinal bleeding within 3 months before screening.
• There was a history of gastrointestinal perforation and/or fistula, a history of intestinal obstruction, and a history of inflammatory bowel disease within 6 months before screening.
• Have a serious history of cardiovascular disease.
• Symptomatic central nervous system metastasis.
• Other malignant tumors confirmed and/or requiring treatment in the past 3 years.
• Be suffering from infectious diseases.
• Have an immune system disease or mental illness that requires treatment.

Sponsors & Collaborators

• Changchun GeneScience Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Shanghai Dongfang Hospital

Shanghai, Shanghai Municipality, 200135, China

RECRUITING

Study Officials

• Jin Li

  Shanghai Dongfang Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shaohua Feng

CONTACT

+86 13917827726; fengshaohua@gensci-china.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: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2023
• First Posted: June 26, 2023
• Study Start: May 30, 2022
• Primary Completion: December 1, 2024
• Study Completion: January 1, 2025
• Last Updated: June 26, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)