Gastric CancerPhase 2NCT04345783
Efficacy and Safety of Camrelizumab for Injection, Apatinib Mesylate and Tegio for First-line Refractory Patients With Advanced Gastric Cancer
A Phase 2 study testing Camrelizumab for injection, apatinib mesylate and tegio in people with Gastric Cancer, run by Beijing Friendship Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Camrelizumab for injection, apatinib mesylate and tegio
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2018to 30 Jun 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Gastric Cancer
- Being tested
- Camrelizumab for injection, apatinib mesylate and tegio
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Camrelizumab for injection, apatinib mesylate and tegioDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Camrelizumab+Apatinib Mesylate+Tegio | Experimental | Not described Receives: Drug: Camrelizumab for injection, apatinib mesylate and tegio |
What is being measured
The primary outcome is the main question the study is designed to answer.
DFS
disease free survival
Measured: 3 years
OS
overall survival
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2020
- Study start1 Jan 2018
- Primary completion31 Dec 2021 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by Beijing Friendship HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhongtao Zhang, Beijing Friendship Hospital
- Investigators
- Wei Deng, M.D., Study director, Beijing Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04345783
- Sponsor's protocol ID
- BFH-CamrelizumabCombo3
- Status last verified
- Apr 2020
- First submitted
- 12 Apr 2020
- Last updated
- 14 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
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
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04345783
- Acronym / sponsor ID
- BFH-CamrelizumabCombo3
- Conditions
- Gastric Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Beijing Friendship HospitalUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 14 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Camrelizumab+Apatinib Mesylate+Tegio | Experimental | Drug: Camrelizumab for injection, apatinib mesylate and tegio |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (7 listed)
- 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.);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Camrelizumab for injection, apatinib mesylate and tegioCamrelizumab 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. | Drug | Camrelizumab+Apatinib Mesylate+Tegio |
Primary outcome
DFS
Time frame: 3 years
disease free survival
OS
Time frame: 3 years
overall survival
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2020.
- Derived from this study: PubMed 35304622Jing 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.
- Individual participant dataSharing planned: Yes
Related trials for Gastric Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
Not yet recruitingPhase 1
GK01 Cell Therapy in Gastric Cancer With Peritoneal Metastasis
Gastric Cancer (GC)
RecruitingPhase 3
A Study of Neoadjuvant-adjuvant Durvalumab and FLOT Chemotherapy Followed by Adjuvant Durvalumab in Chinese Patients With Resectable GC/GEJC.
Gastric, Esophagogastric Junction
Active, not recruitingEarly Phase 1
Iomab-ACT: A Pilot Study of 131-I Apamistamab Followed by CD19-Targeted CAR T-Cell Therapy for Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia or Diffuse Large B-Cell Lymphoma
B-ALL, DLBCL
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wei Deng, M.D. study director
Beijing Friendship Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Camrelizumab for injection, apatinib mesylate and tegio in people with Gastric Cancer, run by Beijing Friendship Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DFS (time frame: 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04345783, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2020.