Camrelizumab Combined With Apatinib in the Treatment of Patients With Advanced Gastric Cancer and Colorectal Cancer

Camrelizumab Combined With Apatinib in the Treatment of Patients With Advanced Gastric Cancer and Colorectal Cancer：One-arm Exploratory Clinical Trial

The efficacy and safety of the use of Camrelizumab combined with Apatinib

Study Overview

• Status: Unknown
• Conditions: Colorectal Cancer Recurrent
• Intervention / Treatment: Drug: Camrelizumab; Drug: Apatinib

Detailed Description

To evaluate the clinical efficacy and safety of Camrelizumab combined with Apatinib in the treatment of patients with advanced gastric cancer and colorectal cancer.

The 62 patients were enrolled in a 2-week regimen with 200mg Camrelizumab given intravenously every two weeks and 250mg apatinib mesylate every 4 weeks for a treatment cycle until progressive or intolerable，then the objective remission rate(ORR) was calculated.

• Study Type: Interventional
• Enrollment (Anticipated): 62
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Li Xiao, Doctor; Phone Number: 0592 2292201; Email: xiaolibohan@163.com

Study Locations

• China
  • Fujian
    • Xiamen, Fujian, China, 361000
      • Recruiting
      • Zhongshan Hospital Affiliated to Xiamen University
      • Contact: Shuntian Cai; Phone Number: +86 18030190632; Email: nktianxingjian@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age 18 - 75 years；
• Patients with histologically or cytologically confirmed advanced or metastatic gastric cancer and colorectal cancer.
• Patients who had previously progressed after receiving standard second-line advanced treatment；
• Patients with at least one evaluable or measurable lesions as per RECIST version 1.1 （CT scan length and diameter of tumor lesion≥10mm，CT scan of lymph node lesion was short diameter≥15mm，scan slice thickness 5mm；）
• ECOG performance status (PS) 0 - 2；
• Life expectancy of at least 3 months；

• Patients with adequate organ function at the time of enrollment as defined below:

  1. Blood routine examination standard：（without blood transfusion within 14 days before enrollment）

     1. Hb ≥90g/L，
     2. WBC≥3.0×109/L
     3. ANC ≥ 1.5×109/L，
     4. PLT ≥ 80×109/L；

  2. Biochemical examination shall meet the following standards：

     1. BIL <1.5 times the upper limit of normal（ULN），
     2. ALT and aspartate aminotransferase (AST) <2.5×upper limit of normal (ULN)，If liver metastasis is present，ALT and AST<5ULN ；
     3. Serum creatinine Cr≤1ULN，Serum creatinine >50ml/min（Cockcroft-Gault math）
• Women of childbearing age in the serum or urine pregnancy test is negative within 7 days prior to study enrollment and must be Non-lactating patients，and agree to use contraceptives (such as intrauterine devices, contraceptives or condoms) during the study period and within 8 months after the end of the study； males should agree to patients who must use contraception during the study period and within 8 months after the end of the study period
• Subjects voluntarily joined the study, signed informed consent, good compliance, and followed up;

Exclusion Criteria:

• Except for other malignant tumors, basal cell carcinoma of the skin and cervical cancer in situ in the past 5 years；
• Patients who have undergone systemic chemotherapy, radiotherapy, surgery, hormone therapy, or immunotherapy <2 weeks before enrollment；
• With severe heart, liver, lung and kidney disease；Significant neurological or psychiatric disorders；Patients with partial or complete gastrointestinal obstruction；
• Patients with a large amount of pleural effusion or ascites requiring drainage；
• Patients with symptomatic brain metastasis；
• Patients with hypertension that is difficult to control (systolic blood pressure ≥140 mmHg and diastolic blood pressure ≥90 mmHg) despite treatment with several hypotensive agents; Patients with acute coronary syndrome (including myocardial infarction and unstable angina), and with a history of coronary angioplasty or stent placement performed within 6 months before enrollment；Patients with acute coronary syndrome（included QTc male>450ms，female>470ms）and cardiac dysfunction；
• Women who are pregnant or breastfeeding；
• Patients with concurrent autoimmune disease, or a history of chronic or recurrent autoimmune disease;
• Patients with concurrent autoimmune disease, or a history of chronic or recurrent autoimmune disease: included HIV positive or a history of organ transplantation and allogeneic bone marrow transplantation;
• Patients with interstitial lung disease with symptoms or signs of activity；
• Patients with a risk of gastrointestinal bleeding may not be enrolled, including the following: (1) active digestive ulcer lesions and fecal occult blood (++); (2) nausea and hematemesis within 2 months Medical history. Simple fecal occult blood (+) is not an exclusion criterion；Coagulation abnormalities （INR>1.5、APTT>1.5ULN）；
• Urine protein ≥ ++ or confirmed 24 hour urine protein quantitation；
• Patients with non-healing wound, non-healing ulcer, or non-healing bone fracture;
• Patients with a seizure disorder who require pharmacotherapy；
• Patients with a history of hypersensitivity to any of the study drugs, similar drugs, or excipients；
• The investigator believes that there are any conditions that may damage the subject or result in the subject being unable to meet or perform the research request;
• participated in other clinical studies before and during treatment；

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Camrelizumab + Apatinib	Drug: Camrelizumab; Camrelizumab One course will last 28 days.Intravenous injection at a dose of 200 mg, q2w One course will last 28 days. Oral administration at a dose of 250 mg/d; Other Names: Apatinib; Drug: Apatinib; Apatinib One course will last 28 days.Oral administration at a dose of 250 mg, qd

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective response rate	Objective response rate (ORR) according to Response Evaluation Criteria in Solid Tumours (RECIST) version. 1.1, and immune-related (ir) RECIST	one year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Treatment-Emergent Adverse-Events	Incidence of adverse events	one year

Collaborators and Investigators

• Sponsor: Zhongshan Hospital Xiamen University
• Investigators: Principal Investigator: Li Xiao, Doctor, Zhongshan Hospital Xiamen University

Study record dates

Study Major Dates

• Study Start (Actual): August 20, 2019
• Primary Completion (Anticipated): September 23, 2020
• Study Completion (Anticipated): October 31, 2021

Study Registration Dates

• First Submitted: August 14, 2019
• First Submitted That Met QC Criteria: August 22, 2019
• First Posted (Actual): August 28, 2019

Study Record Updates

• Last Update Posted (Actual): September 29, 2020
• Last Update Submitted That Met QC Criteria: September 25, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Apatinib
• Other Study ID Numbers: Arise-FJ-R301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No