Gastric or Gastro-oesophageal Junction CarcinomaNCT04713059
Toripalimab Combined With Anlotinib for Patients With Advanced, Relapsed, or Refractory Gastric, or Esophagogastric Junction Cancer (EGJC)
An observational study of Gastric or Gastro-oesophageal Junction Carcinoma and Advanced, Relapsed Gastric or Gastro-oesophageal Junction Carcinoma, run by The Affiliated Hospital of Qingdao University at 1 site in China.
Trial summary
Patients were aged >18 years with histological confirmed GC/EGJC and were refractory to the first line of therapy. Additional eligibility requirements included: ≥1 measurable disease at baseline per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v 1.1); Eastern Cooperative Oncology Group Performance… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Gastric or Gastro-oesophageal Junction Carcinoma, Advanced, Relapsed Gastric or Gastro-oesophageal Junction Carcinoma, Second-line Therapy
- What is being tested?
- FGFR2
- How many people
- 62 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2020to 1 Jan 2023
- Phase
- Observational
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients were aged >18 years with histological confirmed GC/EGJC and were refractory to the first line of therapy.
Who may be able to join
- Patients were aged >18 years with histological confirmed GC/EGJC and were refractory to the first line of therapy. Additional eligibility requirements included: ≥1 measurable disease at baseline per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v 1.1); Eastern Cooperative Oncology Group Performance status of 0 or 1; or life expectancy of ≥ 3 months and adequate organ function.
Who cannot join
- The main exclusion criteria were interstitial lung disease, pulmonary fibrosis, active or prior autoimmune disease or active hepatitis, or history of anlotinib or any other PD-L1/PD-1 antagonist treatment. Patients with abdominal fistula, diverticulitis, gastrointestinal ulcerative disease or perforation, or abdominal abscess within the prior 4 weeks were also excluded.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xiaochun Zhang
Qingdao, 266003
Man Jiang, +8653282913271, jasmanouc@163.com
About this study
Official title: The Affiliated Hospital of Qingdao University
Patients were aged >18 years with histological confirmed GC/EGJC and were refractory to the first line of therapy. Additional eligibility requirements included: ≥1 measurable disease at baseline per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v 1.1); Eastern Cooperative Oncology Group Performance status of 0 or 1; or life expectancy of ≥ 3 months and adequate organ function. The main exclusion criteria were interstitial lung disease, pulmonary fibrosis, active or prior autoimmune disease or active hepatitis, or history of anlotinib or any other PD-L1/PD-1 antagonist treatment. Patients with abdominal fistula, diverticulitis, gastrointestinal ulcerative disease or perforation, or abdominal abscess within the prior 4 weeks were also excluded. This study was an open, exploratory single-arm, phase II trial. Enrolled patients received anlotinib (12mg, po. qd, d1-14) combined with toripalimab (240 mg, inv, over 30 min once every 2 weeks).
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FGFR2Genetic
Mutation of FGFR2
| Study group | Role | What they receive |
|---|---|---|
| patients with CPS ≥ 1 or MSI-H or TMB ≥ 10Mb/MUT | Not described Receives: Genetic: FGFR2 | |
| patients with CPS =0 , MSS and TMB < 10Mb/mut | Not described Receives: Genetic: FGFR2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
Measured: 01.01.2019 to 01.01.2021
6m-PFS
Measured: 01.01.2019 to 01.01.2021
safety
Measured: 01.01.2019 to 01.01.2021
Secondary outcomes (2)
PFS
Measured: 01.01.2019 to 01.01.2021
OS
Measured: 01.01.2019 to 01.01.2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2021
- Study start1 Jan 2020
- Primary completion1 Jan 2021
- Study completion1 Jan 2023 (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 or Gastro-oesophageal Junction CarcinomaStudies of the same condition, open and under way.
- More trials run by The Affiliated Hospital of Qingdao UniversityThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of Qingdao University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, zhangxiaochun, The Affiliated Hospital of Qingdao University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04713059
- Sponsor's protocol ID
- CAANGC/EJGC
- Status last verified
- Jun 2021
- First submitted
- 14 Jan 2021
- Last updated
- 1 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jiang M, Zhang C, Hu Y, Li T, Yang G, Wang G, Zhu J, Shao C, Hou H, Zhou N, Liu K, Zhang X. Anlotinib Combined with Toripalimab as Second-Line Therapy for Advanced, Relapsed Gastric or Gastroesophageal Junction Carcinoma. Oncologist. 2022 Nov 3;27(11):e856-e869. doi: 10.1093/oncolo/oyac136.
PubMed 35857405
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Affiliated Hospital of Qingdao University
- ClinicalTrials.gov ID
- NCT04713059
- Acronym / sponsor ID
- CAANGC/EJGC
- Conditions
- Gastric or Gastro-oesophageal Junction Carcinoma, Advanced, Relapsed Gastric or Gastro-oesophageal Junction Carcinoma, Second-line Therapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- The Affiliated Hospital of Qingdao UniversityUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 1 Jan 2023 (estimated)
- First posted
- 19 Jan 2021 (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.
Patients were aged >18 years with histological confirmed GC/EGJC and were refractory to the first line of therapy. Additional eligibility requirements included: ≥1 measurable disease at baseline per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v 1.1); Eastern Cooperative Oncology Group Performance status of 0 or 1; or life expectancy of ≥ 3 months and adequate organ function. The main exclusion criteria were interstitial lung disease, pulmonary fibrosis, active or prior autoimmune disease or active hepatitis, or history of anlotinib or any other PD-L1/PD-1 antagonist treatment. Patients with abdominal fistula, diverticulitis, gastrointestinal ulcerative disease or perforation, or abdominal abscess within the prior 4 weeks were also excluded. This study was an open, exploratory single-arm, phase II trial. Enrolled patients received anlotinib (12mg, po. qd, d1-14) combined with toripalimab (240 mg, inv, over 30 min once every 2 weeks).
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with CPS ≥ 1 or MSI-H or TMB ≥ 10Mb/MUT | – | Genetic: FGFR2 |
| patients with CPS =0 , MSS and TMB < 10Mb/mut | – | Genetic: FGFR2 |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients were aged >18 years with histological confirmed GC/EGJC and were refractory to the first line of therapy.
Key inclusion criteria (1 listed)
- Patients were aged >18 years with histological confirmed GC/EGJC and were refractory to the first line of therapy. Additional eligibility requirements included: ≥1 measurable disease at baseline per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v 1.1); Eastern Cooperative Oncology Group Performance status of 0 or 1; or life expectancy of ≥ 3 months and adequate organ function.
Key exclusion criteria (1 listed)
- The main exclusion criteria were interstitial lung disease, pulmonary fibrosis, active or prior autoimmune disease or active hepatitis, or history of anlotinib or any other PD-L1/PD-1 antagonist treatment. Patients with abdominal fistula, diverticulitis, gastrointestinal ulcerative disease or perforation, or abdominal abscess within the prior 4 weeks were also excluded.
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 |
|---|---|---|
| FGFR2Mutation of FGFR2 | Genetic | patients with CPS =0 , MSS and TMB < 10Mb/mut, patients with CPS ≥ 1 or MSI-H or TMB ≥ 10Mb/MUT |
Primary outcome
ORR
Time frame: 01.01.2019 to 01.01.2021
6m-PFS
Time frame: 01.01.2019 to 01.01.2021
safety
Time frame: 01.01.2019 to 01.01.2021
2 secondary outcomes
PFS
Time frame: 01.01.2019 to 01.01.2021
OS
Time frame: 01.01.2019 to 01.01.2021
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2021.
- Derived from this study: PubMed 35857405Jiang M, Zhang C, Hu Y, Li T, Yang G, Wang G, Zhu J, Shao C, Hou H, Zhou N, Liu K, Zhang X. Anlotinib Combined with Toripalimab as Second-Line Therapy for Advanced, Relapsed Gastric or Gastroesophageal Junction Carcinoma. Oncologist. 2022 Nov 3;27(11):e856-e869. doi: 10.1093/oncolo/oyac136.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric or Gastro-oesophageal Junction Carcinoma and Advanced, Relapsed Gastric or Gastro-oesophageal Junction Carcinoma, run by The Affiliated Hospital of Qingdao University 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 1 inclusion and 1 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 1 Jul 2021. 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.
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?
Contact Man Jiang (+8653282913271, jasmanouc@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: 01.01.2019 to 01.01.2021). The study lists 3 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 NCT04713059, 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 1 Jul 2021; AzTrials last refreshed its copy on 7 Nov 2026.