CClinicalTrials.gg
Status unknownNCT04345783Updated Apr 14, 2020

Efficacy and Safety of Camrelizumab for Injection, Apatinib Mesylate and Tegio for First-line Refractory Patients With Advanced Gastric Cancer

A Phase 2 interventional study of Camrelizumab for injection, apatinib mesylate and tegio in Gastric Cancer, sponsored by Beijing Friendship Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-04-14.

Sponsored by Beijing Friendship Hospital · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2020), so the status shown — last known as Active, not recruiting — may be out of date.

From the registry’s dates

  • Registered 2 years 3 months after the study started (first participant enrolled Jan 2018, registered Apr 2020).
Phase
Phase 2
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Gastric Cancer

Browse trials for

03

In context

Stomach Neoplasms

2,850 studies on the registry are indexed under Stomach Neoplasms; 863 are open to participants now.

This study's enrollment of 30 is below the median of 67 across 2,095 interventional studies indexed under Stomach Neoplasms.

Browse Stomach Neoplasms studies →

Lead sponsor

Beijing Friendship Hospital is the lead sponsor of 216 studies on the registry; 95 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

    1. Aged 18-75;
    1. ECOG score 0-2;
    1. 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);
    1. Patients with locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma that are refractory to first-line chemotherapy;
    1. Patients who received no previous treatment with apatinib or other VEGFR inhibitors, e.g. sorafenib and sunitinib;
    1. 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;
    1. Without severe dysfunction of heart, lung, liver or kidney, without jaundice and digestive tract obstruction, and without acute infection.

Exclusion criteria

Exclusion Criteria:

    1. KPS \< 60, or estimated survival \< 3 months;
    1. 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;
    1. 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;
    1. Abnormal coagulation (INR > 1.5, APTT > 1.5 ULN), with bleeding tendency;
    1. 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.);
    1. Patients with nervous and mental diseases or with severe infection;
    1. Pregnant or lactating women or those who have fertility requirements during the study period.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    Camrelizumab+Apatinib Mesylate+Tegio

    Drug: Camrelizumab for injection, apatinib mesylate and tegio

Interventions

  • DrugCamrelizumab for injection, apatinib mesylate and tegio

    Camrelizumab for injection: fixed dose of 200 mg, ivgtt for 30 minutes, given on D1, repeat for every 3 weeks; Apatinib mesylate: 250 mg, p.o, qd; Tegio capsule: p.o., bid, D1-14, repeat for every 21 days.

06

What researchers measure

Primary outcomes

  1. DFS

    disease free survival

    Time frame: 3 years

  2. OS

    overall survival

    Time frame: 3 years

07

Study locations

1 site
  • Beijing Friendship Hospital
    Beijing, Beijing 100050, China
08

References and documents

Publications

  • 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. PubMed 35304622 ↗

Individual participant data

Plan to share: Yes

Supporting information: Study protocol, Sap, Icf, Csr, Analytic code

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 14, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04345783
Lead sponsor
Beijing Friendship Hospital
Responsible party
Zhongtao Zhang (Professor, Beijing Friendship Hospital) — Principal investigator
First posted
Apr 14, 2020
Start date
Jan 1, 2018
Primary completion
Dec 31, 2021 (estimated)
Completion
Jun 30, 2022 (estimated)
Last update
Apr 14, 2020

Study contacts

Wei Deng, M.D.
study director · Beijing Friendship Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion