Phase I / II Clinical Study of Albumin-paclitaxel Combined With Apatinib and Camrelizumab in the Second-line Treatment of Advanced Gastric Cancer

China Medical University, China1 site in 1 country52 target enrollmentMarch 2020

ConditionsAdvanced Gastric Cancer

InterventionsAlbumin-paclitaxel, Apatinib, Camrelizumab

DrugsAlbumin-paclitaxel, Apatinib, Camrelizumab

Overview

Phase: Phase 1
Intervention: Albumin-paclitaxel, Apatinib, Camrelizumab
Conditions: Advanced Gastric Cancer
Sponsor: China Medical University, China
Enrollment: 52
Locations: 1
Primary Endpoint: Dose-Limiting Toxicity [DLT]
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This study is to evaluate the tolerance of albumin paclitaxel combined with apatinib and Camrelizumab in the second-line treatment of advanced gastric cancer to determine the maximum tolerable dose (MTD) of the combination.

Detailed Description

This is a Single arm, open, phase I / II clinical trial. The study was divided into tolerance observation stage (dose exploration stage) and efficacy expansion stage (dose expansion stage). This study is to evaluate the tolerance of albumin-paclitaxel combined with apatinib and Camrelizumab in the second-line treatment of advanced gastric cancer to determine the maximum tolerable dose (MTD) of the combination. The secondary objective was to evaluate the safety and efficacy of albumin- paclitaxel in combination with apatinib and Camrelizumab in the second-line treatment of advanced gastric cancer.

Registry

clinicaltrials.gov

Start Date

March 2020

End Date

June 2021

Last Updated

6 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

China Medical University, China

Responsible Party

Principal Investigator

Yunpeng Liu

Director of Department of Medical Oncology，The First Hospital of China Medical University

China Medical University, China

Eligibility Criteria

Inclusion Criteria

•Pathologically diagnosed gastric or gastroesophageal junction adenocarcinoma (GEJ).
•Age: 18-70 years old, Female or Male.
•Failure or intolerance of first-line chemotherapy which requires that the first-line chemotherapy regimen include the scheme based on platinum and / or fluorouracil drugs.
•ECOG performance status 0-
•Patients must have at least 1 lesion that is measurable using RECIST v1.1 criteria. If the progress is confirmed and meets the RECIST 1.1 standard, it can also be used as target lesion.
•An expected survival of \> 12 weeks.
•Be able to swallow tablets normally.
•All acute toxic reactions caused by previous anti-tumor treatment or surgery were relieved to level 0-1 (according to NCI CTCAE version 4.03) or to the level specified in the inclusion / exclusion criteria. Except for other toxicity that researchers think does not pose a safety risk to patients, such as hair loss.
•Has adequate sufficient organ and bone marrow functions.
•Fertile female subjects must undergo a serum-negative pregnancy test within 72 hours before starting the study drug and must agree to use a medically approved effective contraceptive during the study period and within 90 days of the last dose of the study drug; Male subjects whose partners are women of child-bearing age should undergo surgical sterilization or agree to use effective methods of contraception during the study period and within 90 days of the last study administration.

Exclusion Criteria

•Known HER2 positive status.
•The first-line received any taxol drug treatment (if there is tumor recurrence and metastasis during or ≤ 24 weeks after the completion of adjuvant treatment, it is considered that the early-stage adjuvant treatment is a first-line systemic chemotherapy for advanced diseases).
•Previously received PD-1 / PD-L1 antibody, CTLA-4 antibody, or other small molecular inhibitors for PD-1 / PD-L1 and / or VEGFR.
•It is known that it is allergic to apatinib, albumin paclitaxel, carrizumab or drug adjuvant; or it has serious allergic reaction to other monoclonal antibodies.
•Immunosuppressive drugs were used within 14 days before the first use of carrizumab, excluding nasal spray and inhaled corticosteroids or systemic steroids in physiological dose (i.e. no more than 10 mg / day of prednisolone or other corticosteroids in physiological dose of the same drug).
•The live attenuated vaccine shall be inoculated within 4 weeks before the first administration or during the study period.
•Central nervous system (CNS) metastasis or presence of brain edema, spinal cord compression, cancerous meningitis, leptomeningeal disease and / or progressive growth. Patients with central nervous system metastases that have been stable for more than 1 month after surgery or radiotherapy can be enrolled in the study if their clinical manifestations are stable 4 weeks after withdrawal of anticonvulsants and steroids before the first administration of the study.
•The peripheral neuropathy was more than 1 grade.
•Symptomatic, disseminated to the internal organs, and at risk of life-threatening complications in a short period of time (including patients with uncontrolled large amount of exudate \[chest, pericardium, abdominal cavity\], lymphangitis and more than 30% of liver involvement).
•At present, patients with interstitial pneumonia or interstitial lung disease, or with previous history of interstitial pneumonia or interstitial lung disease requiring hormone treatment, or with other pulmonary fibrosis, organic pneumonia (such as bronchiolitis obliterans), pneumoconiosis, drug-related pneumonia, idiopathic pneumonia that may interfere with the judgment and treatment of immune-related pulmonary toxicity, or with active pneumonia on CT at screening stage Patients with severe impairment of pulmonary function; active tuberculosis.

Arms & Interventions

Albumin-paclitaxel Combined With Apatinib and Camrelizumab

Albumin-paclitaxel: ivgtt, 75 or 100 or 125mg /m2, d1, d8; Apatinib: initial dose: 250mg,oral,once a day, after meal ( try to take the medicine at the same time each day); Camrelizumab：ivgtt, 200mg, given on the first day; Repeat the therapeutic schedule every 3 weeks

Intervention: Albumin-paclitaxel, Apatinib, Camrelizumab

Outcomes

Primary Outcomes

Dose-Limiting Toxicity [DLT]

Time Frame: Each 21 days up to Dose-Limiting Toxicity (12-13 months)

Dose-Limiting Toxicity

Secondary Outcomes

Objective Response Rate [ORR](Up to 13-16 months)
Duration of response [DoR](Up to 13-16 months)
Time To Response [TTR](Up to 13-16 months)
Progression Free Survival [PFS](Up to 13-16 months)
Incidence and degree of Adverse Events and Serious Adverse Events [Safety](Until 30 day safety follow-up visit (Up to 14-18 months))
Disease Control Rate [DCR](Up to13-16 months)
Overall Survival [OS](Up to 14-18 months)