Clinical Study of Albumin-paclitaxel Combined With Apatinib and Camrelizumab in Advanced Gastric Cancer

NCT04286711 | Unknown Phase 1

• 1 other identifier: MA-GC-I-002
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Gastric Cancer

Keywords

Apatinib Albumin-paclitaxel Camrelizumab Gastric cancer

Outcome Measures

Primary Outcomes (1)

• Dose-Limiting Toxicity [DLT]

  Dose-Limiting Toxicity

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

Secondary Outcomes (7)

• Incidence and degree of Adverse Events and Serious Adverse Events [Safety]

  Until 30 day safety follow-up visit (Up to 14-18 months)

• 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

• Disease Control Rate [DCR]

  Up to13-16 months

Study Arms (1)

Albumin-paclitaxel Combined With Apatinib and Camrelizumab

EXPERIMENTAL

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

Drug: Albumin-paclitaxel, Apatinib, Camrelizumab

Interventions

Albumin-paclitaxel, Apatinib, Camrelizumab DRUG

Albumin-paclitaxel: ivgtt, 75 or 100 or 125mg /m2, d1, d8, Repeat the therapeutic schedule every 3 weeks; 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, Q3W;

Also known as: Paclitaxel for injection（Albumin Bound），Apatinib Mesylate Tablets，SHR-1210

Albumin-paclitaxel Combined With Apatinib and Camrelizumab

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 0-1.
• 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.

You may not qualify if:

• 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.
• Patients have agreed and signed the informed consent. Willingness and able to follow the planned visit, research treatment, laboratory examination and other test procedures.
• 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.
• There is any active autoimmune disease or a history of autoimmune disease (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism; subjects with vitiligo or asthma in childhood have been completely relieved, and those who do not need any intervention after adulthood can be included Asthma requiring medical intervention with bronchodilator was not included.)
• Any other malignant tumor has been diagnosed within 3 years before the study, except for basal cell or squamous cell skin cancer or cervical carcinoma in situ which has been fully treated.

Sponsors & Collaborators

• China Medical University, China: lead

Study Sites (1)

The First Hospital of China Medical University

Shenyang, Liaoning, 110010, China

Location

Related Publications (5)

• Jemal A, Bray F, Center MM, Ferlay J, Ward E, Forman D. Global cancer statistics. CA Cancer J Clin. 2011 Mar-Apr;61(2):69-90. doi: 10.3322/caac.20107. Epub 2011 Feb 4.

  PMID: 21296855 RESULT

• Cunningham D, Starling N, Rao S, Iveson T, Nicolson M, Coxon F, Middleton G, Daniel F, Oates J, Norman AR; Upper Gastrointestinal Clinical Studies Group of the National Cancer Research Institute of the United Kingdom. Capecitabine and oxaliplatin for advanced esophagogastric cancer. N Engl J Med. 2008 Jan 3;358(1):36-46. doi: 10.1056/NEJMoa073149.

  PMID: 18172173 RESULT

• Catalano V, Graziano F, Santini D, D'Emidio S, Baldelli AM, Rossi D, Vincenzi B, Giordani P, Alessandroni P, Testa E, Tonini G, Catalano G. Second-line chemotherapy for patients with advanced gastric cancer: who may benefit? Br J Cancer. 2008 Nov 4;99(9):1402-7. doi: 10.1038/sj.bjc.6604732.

  PMID: 18971936 RESULT

• Li J, Qin S, Xu J, Guo W, Xiong J, Bai Y, Sun G, Yang Y, Wang L, Xu N, Cheng Y, Wang Z, Zheng L, Tao M, Zhu X, Ji D, Liu X, Yu H. Apatinib for chemotherapy-refractory advanced metastatic gastric cancer: results from a randomized, placebo-controlled, parallel-arm, phase II trial. J Clin Oncol. 2013 Sep 10;31(26):3219-25. doi: 10.1200/JCO.2013.48.8585. Epub 2013 Aug 5.

  PMID: 23918952 RESULT

• Thuss-Patience PC, Kretzschmar A, Bichev D, Deist T, Hinke A, Breithaupt K, Dogan Y, Gebauer B, Schumacher G, Reichardt P. Survival advantage for irinotecan versus best supportive care as second-line chemotherapy in gastric cancer--a randomised phase III study of the Arbeitsgemeinschaft Internistische Onkologie (AIO). Eur J Cancer. 2011 Oct;47(15):2306-14. doi: 10.1016/j.ejca.2011.06.002.

  PMID: 21742485 RESULT

MeSH Terms

Interventions

apatinib; camrelizumab; Paclitaxel

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• YunPeng Liu, PhD

  First Hospital of China Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

YunPeng Liu, PhD

CONTACT

86-24-83282312; cmuliuyunpeng@hotmail.com

Xiujuan Qu, PhD

CONTACT

86-24-83282542; qu_xiujuan@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department of Medical Oncology，The First Hospital of China Medical University

Study Record Dates

• First Submitted: February 25, 2020
• First Posted: February 27, 2020
• Study Start: March 1, 2020
• Primary Completion: August 1, 2020
• Study Completion: June 1, 2021
• Last Updated: February 27, 2020

Record last verified: 2020-02

Locations

CN (1)