Neoplasms

All Conditions

Adenocarcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Albumin-Bound Paclitaxel

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.

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.

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

Gentuximab Injection

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

Gentuximab Injection Placebo

Shaohua Feng

Jin Li

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.

It was planned to enroll 752 subjects, grouped according to a 1:1 ratio, with 376 cases each in the experimental group and the control group.

Screening period:

Screening period assessments were performed within 28 days prior to randomization. Patients are screened after signing the informed consent form (ICF), complete relevant laboratory tests and imaging evaluations (including physical examination, vital signs, height, weight, ECOG score, laboratory tests, 12-lead ECG, echocardiography, chest, abdomen, pelvic contrast/contrast CT and head enhancement MRI, whole body bone scan, etc.), and subjects who meet the inclusion criteria and do not meet the exclusion criteria can be enrolled.

Treatment period:

All eligible participants were randomly assigned to the following two groups in a 1:1 ratio based on stratified factors (time to randomization \< 6 months or ≥ months from the start of first-line therapy):

1. Test group: Gentuximab injection 8 mg/kg, D1, 15 intravenous drip, combined with Paclitaxel injection 80 mg/m2/time, D1, 8, 15 intravenous drip, every 28 days.
2. Control group: placebo 8 mg/kg, D1, 15 intravenous drip, combined with paclitaxel injection 80 mg/m2/time, D1, 8, 15 intravenous drip, every 28 days.

Efficacy and quality of life scores were assessed every 8 weeks ± 7 days according to RECIST 1.1, including chest, abdomen, and pelvis. The safety profile of subjects throughout treatment was evaluated according to NCI-CTCAE V 5.0 criteria, including vital signs, physical examination, ECOG score, laboratory tests, 12-lead ECG, echocardiogram, adverse events, serious adverse events, etc.

Follow-up periods:

Follow-up periods include safety and survival follow-up, immediately after the last study drug is completed.

Safety follow-up: All subjects had a safety follow-up within 28±5 days after the last dose or before starting new antitumor therapy (except for subjects withdrawing informed consent, voluntary withdrawal, loss to follow-up, death, etc.), and performed vital signs, physical examination, weight, ECG score, 12-lead ECG, laboratory tests, etc. (see Table 1.3-1 for details), and recorded concomitant medication and adverse events. If safe follow-up is less than 14 days from the end of treatment (EOT) visit, EOT visit can be an alternative to safe follow-up without repeating.

Survival follow-up: For any subject who ends treatment due to non-disease progression (and does not take other antitumor therapy), it is still necessary to return to the hospital every 8 weeks ± 7 days according to the original tumor evaluation plan for tumor imaging evaluation and life scale evaluation until disease progression, start of new antitumor therapy, withdrawal of informed consent, voluntary withdrawal, loss to follow-up, death, etc. For participants whose disease has progressed or who have started new antineoplastic therapy, survival follow-up is recorded every 8 weeks ±7 days from the time of notification of disease progression or initiation of new antineoplastic therapy (telephone follow-up) and details of subsequent treatment regimens (antineoplastic therapy received after the end of the study drug) until death, loss to follow-up, or the end of the study (whichever occurs first).

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

A Randomized, Double-blind, Parallel Controlled Phase III Study of Gentuximab Injection Combined With Paclitaxel Injection Versus Placebo Combined With Paclitaxel Injection for Advanced Gastric or Gastroesophageal Junction Adenocarcinoma.

Drugs belong to the sponsor before they are put into clinical trials and the site is only a contract research organization; It is an industry practice that intellectual property rights belong to the sponsor.

Change in EORTC QLQ-C30 until the date of first documented progression , assessed up to 36 months.

Change in EQ-5D-3L until the date of first documented progression , assessed up to 36 months.

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

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

TTF:From date of randomization until the date of first documented progression or date of death from any cause or date of discontinuation of treatment due to AE, refusal of treatment, or other reasons (excluding due to good outcomes) ,whichever came first, assessed up to 36 months.

ORR: Overall optimal response was the proportion of participants with CR or PR, assessed up to 36 months.

DCR: From date of first assessment is CR or PR to the first assessment is PD or death from any cause, whichever came first, assessed up to 36 months.

DOR: Overall optimal response was the proportion of participants with CR or PR or SD, assessed up to 36 months.

Changchun GeneScience Pharmaceutical Co., Ltd.

Digestive System Diseases

Rare Diseases

Stomach Neoplasms

Stomach Cancer

Sunitinib

Angiogenesis Inhibitors

Growth Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

25 mg (2 capsules of 12.5 mg) for oral administration

Sunitinib will be orally administered at 25 mg once daily (in the morning without regards to meals) for 4 consecutive weeks followed by a 2-week rest period to comprise a complete cycle of 6 weeks.

Placebo will be orally administered once daily (in the morning without regards to meals) for 4 consecutive weeks followed by a 2-week rest period to comprise a complete cycle of 6 weeks.

Placebo

Markus Moehler, MD

This trial will be conducted to evaluate the efficacy, safety and tolerability of SUNITINIB as add-on therapy with a widely used second-line palliative FOLFIRI chemotherapy in patients with chemo-refractory advanced or metastatic adenocarcinoma of stomach or lower esophagus (mGC).

There is a clear scientific rationale for the use of Sunitinib to treat patients with mGC. Despite recent therapeutic advances, the median overall survival (OS) in patients with mG is still ≤ 12 months. Therefore, newer agents with novel mechanisms of action are desperately needed for treatment of these patients.

In parallel to the efforts in front-line therapy, second-line protocols like irinotecan-based regimens have been established in clinical trials for those patients. As many patients are still in good performance status and present with low tumor burden after failure of first-line chemotherapy, they clearly benefit from second-line treatment.

Sunitinib inhibits the receptor tyrosine kinases (RTKs) involved in tumor proliferation and angiogenesis, specifically the VEGFR, PDGFR, KIT, FLT-3, and RET. The VEGF pathway has been shown to be a significant factor in metastatic gastric cancer.

The safety and efficacy of Sunitinib as single agent for the treatment of mGC has been determined and support the proposed clinical study with FOLFIRI in combination with Sunitinib in the treatment of patients with mGC.

Patients included in this trial suffer from advanced or metastatic adenocarcinoma of stomach or lower esophagus. They have failed to respond at least to one standard palliative first-line therapy (based on docetaxel and/or cisplatin plus 5-FU). Irinotecan/FA/5-FU can be determined as one established second-line treatment to be available for these patients.

Taken together, treatment of those patients with Sunitinib combined with standard chemotherapy FOLFIRI offers the chance to benefit from a new innovative therapy with acceptable side effects.

Sunitinib in Patients With Advanced Gastric Cancer and Treated With FOLFIRI

A Randomized, Placebo-controlled Phase II Trial Investigating SUNITINIB Versus Placebo in Patients With Chemorefractory Advanced Adenocarcinoma of the Stomach or Lower Esophagus Treated With Chemotherapy FOLFIRI

PD Dr Markus Möhler

PD Dr.

Esophageal Cancer

Anti-Infective Agents

Doxorubicin

Liposomal doxorubicin

Fluorouracil

Cisplatin

Anti-Bacterial Agents

Antibiotics, Antitubercular

Antimetabolites

Immunosuppressive Agents

Immunologic Factors

5-fluorouracil

Matthew Kulke, MD

The purpose of this study is to collect information on the anti-tumor activity of the combination doxorubicin, cisplatin, and 5-fluorouracil when given to patients with advanced esophageal or gastric adenocarcinoma. We will also be collecting information about the side effects and safety of this combination.

* Patients will receive cisplatin and doxorubicin intravenously once every 3 weeks. In addition to cisplatin and doxorubicin, patients will receive 5-fluorouracil intravenously as a continuous infusion for the duration of the study. In order to do this, patients will receive an infusion pump that can be carried with them. Treatment cycles will be repeated every 21 days for a maximum of 8 cycles.
* Prior to enrollment in this study and while the patient is receiving the therapy, routine blood tests and x-ryas (including chest x-rays and CT scans) will be performed to check the body's response to the treatment. Blood tests will be checked once a week and chest x-rays and CT scans will be checked every 6 weeks.
* Patients with progressive disease or intolerable side effects will be removed from the study. Patients with stable disease or tumor response will continue therapy for a maximum of 8 cycles.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Gentuximab Combined With Paclitaxel Compared With Placebo Combined With Paclitaxel for Gastric Adenocarcinoma.	NCT05919381	Adenocarcinoma ...	Gentuximab Inje... Gentuximab Inje...	18 Years - 75 Years	Changchun GeneScience Pharmaceutical Co., Ltd.
Sunitinib in Patients With Advanced Gastric Cancer and Treated With FOLFIRI	NCT01020630	Adenocarcinoma	Sunitinib Placebo	18 Years -	Johannes Gutenberg University Mainz
Doxorubicin, Cisplatin, 5-Fluorouracil in Patients With Advanced Adenocarcinoma of the Stomach or Esophagus	NCT00165191	Adenocarcinoma ... Adenocarcinoma ... Adenocarcinoma ...	Doxorubicin Cisplatin 5-fluorouracil	18 Years -	Dana-Farber Cancer Institute
Gentuximab Combined With Paclitaxel Compared With Placebo Combined With Paclitaxel for Gastric Adenocarcinoma.	NCT05919381	Adenocarcinoma ...	Gentuximab Inje... Gentuximab Inje...	18 Years - 75 Years	Changchun GeneScience Pharmaceutical Co., Ltd.
Gentuximab Combined With Paclitaxel Compared With Placebo Combined With Paclitaxel for Gastric Adenocarcinoma.	NCT05919381	Adenocarcinoma ...	Gentuximab Inje... Gentuximab Inje...	18 Years - 75 Years	Changchun GeneScience Pharmaceutical Co., Ltd.

Spots Global Cancer Trial Database for adenocarcinoma of stomach