Neoplasms

All Conditions

Digestive System Diseases

Rare Diseases

Adenocarcinoma

Stomach Neoplasms

Esophageal Neoplasms

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Gastrointestinal Neoplasms

Digestive System Neoplasms

Head and Neck Neoplasms

Gastrointestinal Diseases

Esophageal Diseases

Stomach Cancer

Esophageal Cancer

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Albumin-Bound Paclitaxel

Tubulin Modulators

Antimitotic Agents

Participants receive QL1604 and nab-paclitaxel on Days 1, 8, and 15 of each 28-day cycle. If not disease progression after 4 cycles, participants receive QL1604 monotherapy until disease progression、unacceptable toxicity or up to 2 years.

Participants receive paclitaxel on Days 1, 8, and 15 of each 28-day cycle until disease progression or unacceptable toxicity.

QL1604

Nab-paclitaxel

Shunjiang Yu, CMO

Weijian Guo, Professor

This is a study for participants with advanced gastric or gastroesophageal junction adenocarcinoma who had tumor progression after first-line treatment with platinum and fluoropyrimidine doublet therapy. The study will be conducted in 2 parts.

The first stage is a single-arm clinical trial, and the second stage is a controlled clinical trial.

A Study of QL1604 Plus Nab-paclitaxel Versus Paclitaxel in Subjects With Advanced Gastric Cancer.

A Study of QL1604 Plus Nab-paclitaxel Versus Paclitaxel for Participants With Advanced Gastric or Gastroesophageal Junction Adenocarcinoma That Progressed After Therapy With Platinum and Fluoropyrimidine

Overall survival is defined as time from randomization to death due to any cause.

Objective response rate（ORR）assessed by the investigators according to RECIST 1.1.

Disease control rate（DCR）assessed by the investigators according to RECIST 1.1.

Progression-free survival（PFS）assessed by the investigators according to RECIST 1.1.

Tumor response rate（TRR）assessed by the investigators according to RECIST 1.1.

Area under the concentration-time curve (AUC ) following single dose administration of PD-1

Peak plasma concentration (Cmax) following single dose administration of PD-1

Steady-state trough serum concentrationof multiple Dose Administration of PD-1

Steady-state peak serum concentration of multiple Dose Administration of PD-1

The titer of anti-drug antibodies (ADA)and neutralizing antibodies(Nab).

Qilu Pharmaceutical Co., Ltd.

Lenvatinib

Immunomodulating Agents

Protein Kinase Inhibitors

Enzyme Inhibitors

Patients will be treated with serplulimab combined with lenvatinib and paclitaxel/ Paclitaxel for Injection (Albumin Bound)/Paclitaxel liposomefor 6 cycles, followed by serplulimab combined with lenvatinib maintenance therapy until disease progression, intolerable adverse reactions, or withdrawal of treatment consent.

Serplulimab

135\~175mg/m2 /260mg/m2/135-175mg/m2 d1 q3w

Paclitaxel/Paclitaxel-albumin/Paclitaxel liposome

Lian Liu

Lei Cong

Jing Liang

Zimin Liu

Lu Yue

Aina Liu

Li Zhen

This is a prospective, single arm, multicenter phase II study to assess the effectiveness of Serplulimab, Lenvatinib and Paclitaxel in the treatment of advanced gastric or gastroesophageal junction adenocarcinoma after first-line immunotherapy.

Second-line Treatment With Serplulimab, Lenvatinib, and Paclitaxel in Advanced Gastric Cancer After Prior Immunotherapy

Efficacy and Safety of Serplulimab, Lenvatinib, and Paclitaxel in the Treatment of Advanced Gastric or Gastroesophageal Junction Adenocarcinoma After First-line Immunotherapy: a Prospective, Single-armed Clinical Trial

Objective response rate according to RECIST 1.1

Safety and tolerability based on incidence of treatment-emergent adverse events as assessed by CTCAE

Qilu Hospital of Shandong University

Apatinib

Apatinib Tablets, recommended dose of 850mg

ApatinibTablets

Jin Li, MD

The large-scale phase IV study aims to verify the safety and efficacy of apatinib in patients with advanced gastric cancer or gastroesophageal junction adenocarcinoma after failure of two lines of chemotherapy. Apatinib initiated at a recommended dose of 850mg. However, the starting dose was decided by investigator's choice based on patients' condition. Dose interruption and dose reduction were allowed according to the product label. Treatment continued until disease progression, intolerable toxicity, withdrawal of informed consent, or at investigators' discretion. The primary endpoint was safety, which was assessed by recording the incidence and severity of adverse events.

A Study of Apatinib Tablets in the Treatment of Advanced or Metastatic Gastric Cancer

Safety and Efficacy of Apatinib in Patients With Advanced Gastric or Gastroesophageal Junction Adenocarcinoma After Failure of Two or More Lines of Chemotherapy (Ahead-G201): a Prospective, Single-arm, Multicenter, Phase IV Study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of QL1604 Plus Nab-paclitaxel Versus Paclitaxel in Subjects With Advanced Gastric Cancer.	NCT04435652	Advanced Gastri...	QL1604 Nab-paclitaxel Paclitaxel	18 Years - 80 Years	Qilu Pharmaceutical Co., Ltd.
Second-line Treatment With Serplulimab, Lenvatinib, and Paclitaxel in Advanced Gastric Cancer After Prior Immunotherapy	NCT05585580	Advanced Gastri...	Serplulimab Lenvatinib Paclitaxel/Pacl...	18 Years - 75 Years	Qilu Hospital of Shandong University
Second-line Treatment With Serplulimab, Lenvatinib, and Paclitaxel in Advanced Gastric Cancer After Prior Immunotherapy	NCT05585580	Advanced Gastri...	Serplulimab Lenvatinib Paclitaxel/Pacl...	18 Years - 75 Years	Qilu Hospital of Shandong University
A Study of Apatinib Tablets in the Treatment of Advanced or Metastatic Gastric Cancer	NCT02426034	Advanced Gastri...	ApatinibTablets	18 Years - 75 Years	Jiangsu HengRui Medicine Co., Ltd.

Spots Global Cancer Trial Database for advanced gastric or gastroesophageal junction adenocarcinoma