Neoplasms

Digestive System Diseases

All Conditions

Symptoms and General Pathology

Rare Diseases

Stomach Neoplasms

Recurrence

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Stomach Cancer

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Albumin-Bound Paclitaxel

Tubulin Modulators

Antimitotic Agents

HM30181AK 15 mg tablet + Paclitaxel 10mg, 30mg capsules

Kyung-Mi Park, Ph.D

Sook Ryun Park, M.D, Ph.D

Yung-Jue Bang, M.D, Ph.D

Yung-Jue Bang, MD. Ph.D

The main objectives of this study are to determine the maximum tolerated dose (MTD) and recommend dose (RD) of Oraxol® in Phase I and to determine the objective response rate of Oraxol® in Phase II.

Administration Schedule: 1 cycle of Oraxol® is 28 days and Oraxol® is administrated twice a week, total 6 times per cycle (day 1,2,8,9,15 and 16).

A Study of Oraxol® in Gastric Cancer Patients

A Phase I-II Clinical Trial to Determine Recommended Dose and to Assess the Efficacy, Safety and Pharmacokinetic Profile of Oral Paclitaxel(Oraxol®) in Patients With Advanced/Metastatic or Recurrent Gastric Cancer

Toxicity will be evaluated by medical history, vital signs, physical examination and laboratory tests performed during the screening period (D-28 to D0) and treatment period based on NCI-CTCAE (version 3.0).

It is measured up to confirmation of tumor response(CR, PR)

Tumor response will be evaluated by RECIST v1.0.

Hanmi Pharmaceutical Company Limited

Apatinib

Protein Kinase Inhibitors

Enzyme Inhibitors

Apatinib 500mg qd p.o and Sintilimab 200mg intravenously on day 1 every 3 weeks until disease progression or intolerable toxicity or patients withdrawal of consent

Apatinib 500mg qd, oral, taken half an hour after a meal

Apatinib Mesylate

Sintilimab

Nanfeng Fan, MD

JIE LIU, MD

The purpose of this study is to assess the efficacy and safety of Apatinib combined with PD-1 antibody Sintilimab for for Chemotherapy-Refractory Advanced Metastatic Gastric Cancer

Patients with advanced gastric cancer (AGC) can be treated with multiple lines of chemotherapy. After second-line treatment some patients may receive third- and subsequent lines of chemotherapy if their performance status is well-preserved and they are willing to receive subsequent active treatments. Apatinib is a small-molecule VEGFR-2 tyrosine kinase inhibitor approved by the CFDA for the treatment of advanced gastric cancer. In a phase III trial, apatinib significantly improved PFS and OS compared with placebo, but the clinical benefit was modest. As a result of toxicity, 850 mg/day Apatinib may cause dose reduction and delay in some patients ,which also caused some doubts. Therefore, it is a reasonable treatment strategy by reducing the dose and combining it with another low-toxic drug to achieve similar or better effects. Some studies have shown that the combination of targeted therapy and immunotherapy may be effective in solid tumor. Sintilimab (IBI308) is a monoclonal antibody targeting programmed death-1 (PD-1). So, the investigators designed an open-label, single-arm, phase II clinical study to evaluate the efficacy and safety of apatinib combined with Sintilimab in Chemotherapy-Refractory Advanced Metastatic Gastric Cancer.

Apatinib Plus Sintilimab in Advanced Gastric Cancer Refractory to at Least Two Previous Chemotherapy Regimens

Apatinib Plus Sintilimab in Patients With Advanced Gastric Cancer

The percentage of patients who have achieved complete response, partial response and stable disease,evaluated by RECIST, confirmed at least 4 weeks following the date of the initial response.

The percentage of patients who achieve complete response or partial response,evaluated by RECIST, confirmed at least 4 weeks following the date of the initial response.

Overall survival (OS) was calculated from the date of initial treatment with apatinib to the date of death due to any cause.

Time from date of first RECIST response to progressive disease \[PD\] or death

PFS was calculated from the day of randomization to the date of first documented progression, or death from any cause.

Adverse events assessed using the NCI common toxicity criteria, version 4.01

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Study of Oraxol® in Gastric Cancer Patients	NCT01491217	Advanced Metast... Recurrent Gastr...	Paclitaxel	19 Years -	Hanmi Pharmaceutical Company Limited
Apatinib Plus Sintilimab in Advanced Gastric Cancer Refractory to at Least Two Previous Chemotherapy Regimens	NCT04089657	Advanced Metast...	Apatinib Mesyla... Sintilimab	20 Years - 75 Years	Fujian Cancer Hospital

Spots Global Cancer Trial Database for advanced metastatic gastric cancer