Apatinib Monotherapy Versus Apatinib Combined With Camrelizumab for Third-line Treatment of Metastatic Gastric Cancer

NCT05095636 | Unknown Phase 2

• 1 other identifier: FDZL-CAP
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

This open, single-center, randomized phase II study was to evaluate the clinical benefit of apatinib plus camrelizumab which is an anti-Programmed cell death-1 (PD-1) monoclonal antibody, versus apatinib in patients with metastatic gastric cancer refractory to two or more lines of treatment, fully evaluating the efficacy and safety of the combined regimen.

Conditions

Gastric Cancer; Metastasis

Keywords

gastric cancer; target therapy; metastasis; apatinib; anti-PD-1 antibody

Outcome Measures

Primary Outcomes (1)

• PFS

  progression free survival

  Time Frame: from the time signing of ICF until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months

Secondary Outcomes (5)

• OS

  from the time signing of ICF until the date of death from any cause, assessed up to 36 months

• DoR

  the time between the first tumor evaluation for CR or PR and the first evaluation for PD(Progressive Disease) or death from any cause, assessed up to 36 months

• ORR

  the rate of patients with CR and PR, through study completion, an average of 1 year

• DCR

  the rate of patients with CR, PR and SD, through study completion, an average of 1 year

• AEs

  the adverse events rate and types of all enrolled patients, through study completion, an average of 1 year

Study Arms (2)

apatinib monotherapy

ACTIVE COMPARATOR

Apatinib，500 mg，po., qd, q2w

Drug: Apatinib Mesylate

Apatinib Combined With Camrelizumab

EXPERIMENTAL

Apatnib，250 mg，po., qd，q2w; Camrelizumab，200mg， ivgtt，d1, q2w

Drug: Apatinib Mesylate; Drug: Camrelizumab

Interventions

Apatinib Mesylate DRUG

oral Apatinib once everyday

Apatinib Combined With Camrelizumab; apatinib monotherapy

Camrelizumab DRUG

intravenous camrelizumab 200mg once every two weeks

Apatinib Combined With Camrelizumab

Eligibility Criteria

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

You may qualify if:

• Age ≥18;
• Locally advanced or recurrent/metastatic gastric or gastroesophageal junction adenocarcinoma confirmed by histopathological examination;
• Standard treatment failure of no less than two lines of systematic treatment (treatment failure is defined as intolerance of toxic and side effects, disease progression during treatment or recurrence after treatment);
• With one or more measurable lesions, the longest diameter measured by spiral CT scan should be at least 10 mm, and the longest diameter measured by conventional CT scan should be at least 20 mm (RECIST standard, version 1.1);
• ECOG score was 0-2;
• Life expectancy ≥12 weeks;
• The patient has recovered from damage caused by other anti-tumor therapy, received cytotoxic drugs, radiotherapy or surgery for ≥4 weeks, and the wound has completely healed;
• Bone marrow capacity and liver and kidney function were sufficiently reserved 7 days before screening: absolute neutrophil (ANC) count ≥1.5x109 /L; Hemoglobin ≥ 8.0g/ dL; Platelet count ≥80 x109 /L; Total bilirubin \< 1.5 times upper normal limit (ULN); ALT and AST\< 2.5x ULN (with liver metastasis \<5x ULN); Serum creatinine ≤1 x ULN, the clearance rate of endogenous creatinine \>50ml/min;
• Women of childbearing age should take effective contraceptive measures;
• Subjects voluntarily joined the study and signed informed consent with good compliance and follow-up.

You may not qualify if:

• A history of other malignant tumors within 5 years, except cured cervical carcinoma in situ or basal cell carcinoma of the skin;
• Patients with hypertension that could not be controlled by antihypertensive medication (systolic blood pressure \>140mmHg, diastolic blood pressure \>90mmHg), coronary heart disease of grade I or above, arrhythmia of grade I or above (including prolonged QTc interval \> 450ms in males and \> 470 ms in females) and cardiac dysfunction of grade I or above;
• Symptomatic brain or meningeal metastases (unless the patient was treated for \>6 months, imaging results were negative within 4 weeks prior to study entry, and tumor-related clinical symptoms were stable at study entry);
• with a history of uncontrolled epileptic seizures, central nervous system dysfunction, or mental disorders;
• Uncontrolled pleural or abdominal effusion;
• Undergoing kidney dialysis;
• severe or uncontrolled infection;
• pregnant or lactating women who are fertile but have not taken adequate contraceptive measures;
• Multiple factors affecting oral medication (inability to swallow, chronic diarrhea and intestinal obstruction);
• Abnormal coagulation function (PT\>16s, APTT\>43s, TT\>21s, Fbg\< 2G /L), bleeding tendency or receiving thrombolytic or anticoagulant treatment;
• patients with gastrointestinal bleeding risk should not be enrolled, including the following conditions :(1) active peptic ulcer lesions and fecal occult blood (++); (2) patients with history of black stools and hematemesis within 3 months;
• Prior exposure to any anti-PD-1 or anti-PD-L1, PD-L2, CD137, CTLA-4 antibody therapy, or any other antibody or drug that specifically targets T-cell costimulation or immune checkpoint pathways.
• Participated in clinical trials of other drugs within four weeks
• Urine routine examination indicated urine protein \> 2+
• Received systemic systemic therapy with anti-tumor indications of Chinese herbal medicine or immunomodulatory drugs (including thymosin, interferon, interleukin, etc.) within 2 weeks before the first administration;

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms; Neoplasm Metastasis

Interventions

apatinib; camrelizumab

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Xiaodong Zhu, MD

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chenchen Wang, MD

CONTACT

+8613774232040; wccnancy2003@aliyun.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 2, 2021
• First Posted: October 27, 2021
• Study Start: March 17, 2021
• Primary Completion: March 1, 2023
• Study Completion: September 1, 2023
• Last Updated: October 27, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)