Clinical trial NCT04345783: Efficacy and Safety of Camrelizumab for Injection, Apatinib Mesylate and Tegio for First-line Refractory Patients With Advanced Gastric Cancer
Official title: A Study on the Efficacy and Safety of Camrelizumab for Injection, Apatinib Mesylate and Tegio for First-line Refractory Patients With Advanced Gastric Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Gastric Cancer
Lead sponsor: Beijing Friendship Hospital
Sponsor class: OTHER
First posted: 2020-04-14
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a prospective, single-center, single-arm, open-label clinical study, aiming at evaluating the efficacy and safety of camrelizumab for injection, apatinib mesylate and tegio for first-line refractory patients with advanced gastric cancer.


Eligibility criteria: Inclusion Criteria:

* 1. Aged 18-75;
* 2. ECOG score 0-2;
* 3. Pathologically diagnosed late-stage adenocarcinoma of stomach or gastroesophageal junction, with extra-gastric measurable lesions (spiral CT scan≥10 mm, meeting RECIST 1.1 criteria);
* 4. Patients with locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma that are refractory to first-line chemotherapy;
* 5. Patients who received no previous treatment with apatinib or other VEGFR inhibitors, e.g. sorafenib and sunitinib;
* 6. Normal blood routine examination: Neutrophil count ≥ 1.5 × 109 / L; Hemoglobin ≥ 80 g / L; Platelet count ≥ 100 × 109 / L; Total bilirubin ≤ 1.5 × ULN; ALT, AST≤2.5×ULN；
* 7. Without severe dysfunction of heart, lung, liver or kidney, without jaundice and digestive tract obstruction, and without acute infection.

Exclusion Criteria:

* 1. KPS \< 60, or estimated survival \< 3 months;
* 2. Patients with cardiovascular and cerebrovascular events within half a year; patients with uncontrollable hypertension (systolic pressure \> 140 mmHg, diastolic pressure \> 90 mmHg), coronary heart disease above grade I, arrhythmia (including QTc interval prolongation \> 450 ms in men, 470 MS in women) and grade I cardiac dysfunction; patients positive of urine albumin;
* 3. Patients with definite tendency of gastrointestinal bleeding, local active ulcer focus, and occult blood in stool (+ +); patients with history of black stool and hematemesis within 2 months;
* 4. Abnormal coagulation (INR \> 1.5, APTT \> 1.5 ULN), with bleeding tendency;
* 5. Patients with factors that can affect the absorption of oral-intake drugs (such as inability to swallow, nausea, vomiting, chronic diarrhea and intestinal obstruction, etc.);
* 6. Patients with nervous and mental diseases or with severe infection;
* 7. Pregnant or lactating women or those who have fertility requirements during the study period.

Primary outcomes:
measure: DFS
timeFrame: 3 years
measure: OS
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Friendship Hospital
state: Beijing
Study officials:
affiliation: Beijing Friendship Hospital
name: Wei Deng, M.D.
role: STUDY_DIRECTOR
References:
citation: Jing C, Wang J, Zhu M, Bai Z, Zhao B, Zhang J, Yin J, Yang X, Liu Z, Zhang Z, Deng W. Camrelizumab combined with apatinib and S-1 as second-line treatment for patients with advanced gastric or gastroesophageal junction adenocarcinoma: a phase 2, single-arm, prospective study. Cancer Immunol Immunother. 2022 Nov;71(11):2597-2608. doi: 10.1007/s00262-022-03174-9. Epub 2022 Mar 18.