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

NCT04089657 | Unknown Phase 2

• 1 other identifier: APAICI
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Advanced Metastatic Gastric Cancer

Outcome Measures

Primary Outcomes (1)

• Disease control rate(DCR)

  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.

  12 months

Secondary Outcomes (5)

• Objective Response Rate (ORR)

  12 months

• Overall survival (OS)

  up to 12 months

• Duration of Response (DOR)

  up to 12 months

• Progression Free Survival (PFS)

  up to 12 months

• Adverse events（AE）

  up to 12 months

Study Arms (1)

Apatinib+Sintilimab

EXPERIMENTAL

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

Drug: Apatinib Mesylate; Drug: Sintilimab

Interventions

Apatinib Mesylate DRUG

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

Also known as: Apatinib

Apatinib+Sintilimab

Sintilimab DRUG

Sintilimab 200mg intravenously on day 1

Also known as: IBI308

Apatinib+Sintilimab

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 20-75 years old
• Has histologically confirmed diagnosis of unresectable locally advanced,recurrent or metastatic gastric or GEJ adenocarcinoma
• Life expectancy of more than 3 months
• Eastern Cooperative Oncology Group (ECOG) performance status was 0 - 1
• Have failed for at least 2 lines of chemotherapy
• At least 3 weeks from previous chemotherapy at first dose of trial drug
• Resolution of all acute toxic side effects of prior therapy or surgical procedures to grade ≤ 1 National Cancer Institute-Common Toxicity Criteria (NCI-CTC) (except for the laboratory values)
• Failure of prior palliative chemotherapy/chemotherapies (at least one irinotecan- or cisplatin-based). Failure is defined either by progression of disease or by significant toxicity that precludes further treatment.
• At least one measurable lesion defined by RECIST 1.1 as determined by investigator assessment.
• Has adequate organ function
• At least 4 weeks from any major surgery (at first dose of trial drug)
• Patients must be able to swallow apatinib

You may not qualify if:

• In the past, participants have received anti PD-1, anti PD-L1 or anti PD-L2 drugs or drugs targeting another stimulation or synergistic inhibition of T cell receptors (such as Cytotoxic T-Lymphocyte Antigen 4 \[CTLA-4\] and CD137)
• Other co-existing malignancies or malignancies diagnosed within the last 5 years(except cured cutaneum carcinoma or carcinoma in situs of cervix)
• Less than 4 weeks from the last clinical trial
• Active and uncontrollable bleeding from gastrointestinal tract
• Known history of QT interval prolongation, ongoing QT prolongation (\> 450 msec for males or \> 470 msec for females), any cardiac ventricular dysrhythmias, atrial fibrillation of any grade
• Hypertension that cannot be controlled by medications (\> 140/90 mmHg despite optimal medical therapy)
• Abnormal Coagulation (INR\>1.5、APTT\>1.5 UNL), with tendency of bleed;
• Factors that could have an effect on oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction);
• Active uncontrolled infection
• Known human immunodeficiency virus (HIV) infection
• Symptomatic central nervous metastasis and/or cancerous meningitis
• Known allergic/hypersensitivity reaction to any of the components of the treatment; or known drug abuse/alcohol abuse
• Pregnant or lactating women

Sponsors & Collaborators

• Fujian Cancer Hospital: lead

MeSH Terms

Interventions

apatinib; sintilimab

Study Officials

• Nanfeng Fan, MD

  Fujian Cancer Hospital

  STUDY CHAIR

Central Study Contacts

Nanfeng Fan, MD

CONTACT

008613705007267; Nanfeng_Fan@sina.com

JIE LIU, MD

CONTACT

008613860632919; dr2868@sina.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2019
• First Posted: September 13, 2019
• Study Start: December 1, 2019
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2021
• Last Updated: September 13, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share