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

• Status: Not yet recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fujian Cancer Hospital
• Treatments: Apatinib

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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