Clinical trial · Interventional
Efficacy and Safety of Camrelizumab for Injection, Apatinib Mesylate and Tegio for First-line Refractory Patients With Advanced Gastric Cancer
A Study on the Efficacy and Safety of Camrelizumab for Injection, Apatinib Mesylate and Tegio for First-line Refractory Patients With Advanced Gastric Cancer
NCT04345783CI-TRIAL-00044633unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Camrelizumab for injection, apatinib mesylate and tegio | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Camrelizumab+Apatinib Mesylate+Tegio
- interventionNames
- Drug: Camrelizumab for injection, apatinib mesylate and tegio
Primary outcomes (2)
- measure
- DFS
- timeFrame
- 3 years
- description
- disease free survival
- measure
- OS
- timeFrame
- 3 years
- description
- overall survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDJing 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. PMID 35304622