PD-1 Antibody + Apatinib Mesylate in 2+ Line Serum AFP-elevated Gastric Adenocarcinoma

NCT04006821 | Unknown Phase 2

• 1 other identifier: PD-1-APTN-Ⅱ-AFPGC
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of PD-1 antibody combined with apatinib mesylate in patients with unresectable, local advanced recurrent or metastatic serum AFP-elevated gastric adenocarcinoma, who have at least received first-line antitumor therapy or whose standard treatment is intolerable.

Conditions

Gastric Cancer; AFP

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR)

  The proportion of patients whose best overall response (BOR) is complete response (CR) or partial response (PR) assessed by iRECIST v1.1

  2 years

Secondary Outcomes (8)

• Progression-free survival (PFS)

  2 years

• Overall survival (OS)

  2 years

• 6-month/9-month/12-month survival rate

  6-month/9-month/12-month

• Duration of response (DOR)

  2 years

• Disease control rate (DCR)

  2 years

Study Arms (1)

PD-1 antibody + Apatinib mesylate

EXPERIMENTAL

Every patient will receive PD-1 antibody 200mg iv every 2 weeks and apatinib 250mg or 500mg (according to the patient's tolerance) orally every day. PD-1 antibody will be administered until disease progression or lasts for two years. Apatinib mesylate will be administered until disease progression.

Drug: PD-1 antibody; Drug: Apatinib mesylate

Interventions

PD-1 antibody DRUG

Camrelizumab will be administered 200mg iv every 2 weeks until disease progression or lasts for two years.

Also known as: Camrelizumab

PD-1 antibody + Apatinib mesylate

Apatinib mesylate DRUG

Apatinib mesylate will be administered 250mg or 500mg (according to the patient's tolerance), qd, oral, until disease progression.

PD-1 antibody + Apatinib mesylate

Eligibility Criteria

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

You may qualify if:

• Patients must volunteer to participate in the study, signed informed consent, and were able to comply with the program requirements of visits and related procedures.
• Age and gender: ≥18 years old and≤75 years old, both men and women.
• All subjects must have unresectable, local advanced recurrent or metastatic gastric cancer, and have histologically confirmed predominant adenocarcinoma with serum AFP-elevated (serum AFP \> 20 ng/ml).
• Subject must have at least received first-line antitumor therapy or whose standard treatment is intolerable.
• Subject must have at least one measurable lesion or evaluable disease by CT or MRI per iRECIST 1.1 criteria.
• Subject must be previously untreated with anti-angiogenesis molecular targeted therapy and immunotherapy for gastric cancer (including anti-CTLA-4, PD-1/PD-L1 monoclonal antibody immunotherapy).
• ECOG performance status score of 0 or 1.
• Child-Pugh score \< 6 (Child-Pugh A), and no history of hepatic encephalopathy.
• Expected survival: ≥12 weeks.
• Adequate bone marrow, hepatic and renal function as assessed by the following laboratory requirements conducted within 7 days of starting study treatment:
• Neutrophil count≥1.5×10\^9/L; Platelet count≥80×10\^9/L; Hemoglobin≥90g/L; Serum albumin≥28g/L; Total bilirubin (TBI)≤1.5×ULN; Alanine aminotransferase (ALT)≤3×ULN (or≤5×ULN if liver metastases are present); Aspartate aminotransferase (AST)≤1.5×ULN (or≤5×ULN if liver metastases are present); Alkaline phosphatase (ALP)≤2.5×ULN Thyrotropin (TSH) ≤1×ULN (FT3 and FT4 levels should be examined at the same time if abnormal, such as FT3 and FT4 levels are normal, can be included in the group); Serum creatinine≤1.5×ULN or calculated creatinine clearance≥40 mL/min (using the Cockcroft-Gault formula) Female CrCl = (140- age in years) × weight in kg × 0.85 / 72 × serum creatinine in mg/ dL Male CrCl = (140- age in years) × weight in kg × 1.00 / 72 × serum creatinine in mg/ dL Subjects not receiving anticoagulation therapy: INR or APTT ≤ 2×ULN; Urine protein \< 2+; 24-hour urinary protein content \<1.0g/24-hour if urinary protein ≥2+;
• Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test within 72 hours prior to the start of study drug. WOCBP must agree to follow instructions for method(s) of contraception (e.g. intrauterine devices, contraceptives or condoms) for the duration of study treatment and 3 months after the last dose of study treatment. Subjects must be non-lactating. Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of study treatment and 3 months after the last dose of study treatment.
• If HBsAg (+) and/or HBcAb (+), HBV DNA is required to be \<500 IU/mL, and the original anti-HBV treatment is continued throughout the study period, or start to anti-HBV treatment throughout the study.

You may not qualify if:

• With history of active autoimmune disease or autoimmune disease (For example, the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary, vasculitis, nephritis, hyperthyroidism; patients with vitiligo; in childhood asthma has been completely alleviated, adults without any intervention can be included; asthma with medical intervention could not be included). Substitution therapy is not considered as systemic therapy. Patients with the following diseases are not excluded and may proceed to further screening:
• Controlled Type I diabetes
• Hypothyroidism (provided it is managed with hormone replacement therapy only)
• Any condition that required systemic treatment with either corticosteroids (\> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication ≤ 14 days before randomization.
• A history of severe allergy to any monoclonal antibody or anti-angiogenesis targeted drug.
• Patients with known central nervous system metastasis (suspected need to be excluded by MRI scans) or a history of hepatic encephalopathy.
• The total volume of liver metastases\>50%, or obvious infiltration of bile duct or portal vein trunk, or patients who have received liver transplantation in the past.
• More than a small amount of pericardial effusion, uncontrollable pleural effusion or ascites requiring frequent drainage or medical intervention.
• Uncontrollable hypertension with drugs (systolic pressure ≥140 mmHg or diastolic pressure≥90 mmHg).
• With history of serious cardiovascular and cerebrovascular diseases:
• Any history of heart failure meeting New York Heart Association Classification III or IV ≤3 months before randomization； Left ventricular ejection fraction \< 50% by color Doppler echocardiography； Uncontrolled arrhythmias or unstable angina pectoris； Corrected QT interval \> 500ms (calculated by Fridericia method).
• Abnormal coagulation function (INR \> 2.0, PT \> 16s), with haemorrhagic tendency or undergoing thrombolytic or anticoagulant therapy, but prophylactic use of low-dose aspirin and low-molecular-weight heparin is allowed.
• Significant clinical bleeding symptoms or definite bleeding tendency occurred within 3 months before randomization.
• Arteriovenous thrombosis events occurring within 6 months before randomization.
• Hereditary or Acquired Hemorrhage and Thrombosis Tendency.

Sponsors & Collaborators

• China Medical University, China: lead

Study Sites (1)

Cancer Hospital of China Medical University/Liaoning Cancer Hospital &Institute

Shenyang, Liaoning, 110042, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

spartalizumab; camrelizumab; apatinib

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Jingdong Zhang

  China Medical University, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qian Dong

CONTACT

17309815028; dongqian08@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: July 1, 2019
• First Posted: July 5, 2019
• Study Start: July 25, 2019
• Primary Completion: August 1, 2022
• Study Completion: August 1, 2022
• Last Updated: September 30, 2021

Record last verified: 2021-09

Locations

CN (1)