Gastric CancerPhase 2NCT04202484
Tripletrumab Combined With Oxaliplatin and Teggio (SOX) in First-line Treatment of Gastric and Gastroesophageal Junction Adenocarcinoma
A Phase 2 study testing Toripalimab combined with oxaliplatin and Tegafur,Gimeracil and Oteracil Porassium Capsules in people with Gastric Cancer, run by RenJi Hospital.
Trial summary
The aim population is histopathologically confirmed locally unresectable advanced recurrent or metastatic adenocarcinoma of the gastric and gastroesophageal junction. Purpose of research to evaluate the efficacy and safety of tripletrumab combined with oxaliplatin and teggio (SOX) in first-line treatment of… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Toripalimab combined with oxaliplatin and Tegafur,Gimeracil and Oteracil Porassium Capsules
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2020to 1 Feb 2023
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-80;
- Radiographic findings were consistent with non-resectable locally advanced, recurrent or metastatic gastric and gastroesophageal junction adenocarcinoma;
- Non-resectable locally advanced, recurrent or metastatic adenocarcinoma of the gastric and gastroesophageal junction (including sig-ring cell carcinoma and adhesion) confirmed by histopathological examination Liquid adenocarcinoma, hepatoid adenocarcinoma);
- ECOG 0-1;
- Adequate organ and bone marrow function, as defined below:
- 1) blood routine examination: absolute neutrophil count (ANC) ≥1.5×109/L; platelet count (PLT) ≥85×109/L; hemoglobin (HGB) 90 g/L or higher; 2) liver function: total bilirubin (TBIL) ≤2× normal upper limit (ULN) was required in patients without liver metastasis; alanine aminotransferase (ALT) and amino transferase (AST) ≤2.5×ULN.Requirements for patients with liver metastasis: serum total bilirubin (TBIL) ≤2× normal upper limit (ULN); alanine ammonia ALT and AST were ≤5×ULN; 3) renal function: creatinine clearance rate (Ccr) ≥60mL/min; 4) full coagulation function, defined as the international standardized ratio (INR) or prothrombin time (PT) ≤1.5 ULN; 6. According to RECIST v1.1, there is at least one measurable lesion or evaluable lesion; 7. Previous (new) adjuvant chemotherapy/adjuvant radiotherapy ending time to disease recurrence time >6 months; 8. Expected survival time ≥12 weeks; 9. Female subjects of child-bearing age or male subjects whose sexual partners are female of child-bearing age shall take effective contraception throughout the treatment period and 6 months after the treatment period measures; 10. Subjects voluntarily participate in the study, sign the informed consent, and comply with the protocol visit and related procedures.
Who cannot join
- Adenocarcinoma of the gastric and gastroesophageal junction diagnosed as HER2 positive; Previous exposure to any anti-pd-1 or anti-pd-l1, pd-l2, CD137, ctla-4 antibody therapy, or any other antibodies or drugs specifically targeting T cell co-stimulation or checkpoint pathways; Previous systematic treatment for advanced or metastatic adenocarcinoma of the gastric and gastroesophageal junction;
- Participate in another interventional clinical study, unless participating in an observational (non-interventional) clinical study or in the follow-up phase of the interventional study;
- Patients with autoimmune diseases or abnormal immune system;
- The history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation is known; uncontrolled high blood pressure, diabetes and heart disease;
- Cardia and pylorus are nearly obstructed, affecting the patient's eating and stomach emptying, or swallowing tablets is obstructed; The signs of lesion activity bleeding under endoscopy are known;
- Known active tuberculosis; Interstitial lung disease requiring steroid ormone therapy;
Show all 13Show fewer
- A known history of human immunodeficiency virus (HIV) infection (i.e. HIV antibody positive); Acute or chronic active hepatitis b (HBsAg positive with HBV DNA viral load ≥200 IU/mL or ≥103 copy number /mL) or acute or chronic active hepatitis c (HCV antibody positive and HCV RNA positive) is known.
- Severe infections in the active phase or poorly controlled clinically;
- History of other primary malignant tumors, except: malignant tumors that had been in complete remission for at least 2 years before enrollment and did not require other treatment during the study period; Non-melanoma skin cancer or malignant freckle mole with adequate treatment and no evidence of disease recurrence; Carcinoma in situ with adequate treatment and no evidence of disease recurrence;
- Female patients who are pregnant or breastfeeding;
- Known allergy to any monoclonal antibody or component of the preparation of chemotherapy drugs (teggio, oxaliplatin) (grade 3 or higher);
- Clinically significant ascites, including any ascites that can be found on physical examination, ascites that have been previously treated or are still in need of treatment, with only a small amount of ascites shown on imaging but no symptoms, can be included. Patients with bilateral medium pleural effusion, or large pleural effusion, or respiratory dysfunction requiring drainage;
- Other acute or chronic diseases, mental illnesses, or laboratory abnormalities that may result in increased risk of study participation or study drug administration, or interfere with the interpretation of the study results, and in the judgment of the investigator, the patient is not eligible to participate in the study.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Prospective, Single-arm, Exploratory Clinical Research on the Efficacy and Safety of Tripletrumab Combined With Oxaliplatin and Teggio (SOX) in First-line Treatment of Unresectable Locally Advanced or Metastatic Gastric and Gastroesophageal Junction Adenocarcinoma
The aim population is histopathologically confirmed locally unresectable advanced recurrent or metastatic adenocarcinoma of the gastric and gastroesophageal junction. Purpose of research to evaluate the efficacy and safety of tripletrumab combined with oxaliplatin and teggio (SOX) in first-line treatment of unreactable locally advanced, recurrent or metastatic gastric and gastroesophageal junction adenocarcinoma.
Every 21 days is a cycle, and treatment is scheduled for 6 cycles. Chemotherapy drugs until disease progression, toxicity intolerance, the start of new anti - tumor treatment, withdrawal, loss of access or death, etc., already reached first, shall be the basis for termination.
Read more
Treatment was effective for more than 6 treatment cycles and toxicity was, the subjects were judged by the researchers when to terminate the treatment and adjust the follow-up treatment plan.
For disease progression, toxicity intolerance, and initiation of new antitumor therapies.
For subjects who donot reach terminal events such as treatment, withdrawal, loss of follow-up or death, at the end of chemotherapy , the follow-up maintenance regimen was adjusted according to the researchers' evaluation.
The screening period of the study was 14 days. The screening test was completed and the evaluation was completed.
Subjects with standard discharge entered the treatment period, and the frequency of administration was determined according to the protocol.
Conduct treatment and complete relevant tests and assessments before each administration.
Tumor imaging was assessed every 6 weeks (±7 days) and all subjects were treated.
At the end of the visit, safety and imaging evaluations should be completed. Complete follow-up was conducted for a total of 90 days. Continue to receive tumor evaluation and imaging at a frequency of 2-3 months. Evaluation until disease progression, new antitumor therapy, withdrawal, Lost or dead, etc.
- Conditions
- Gastric Cancer
- Being tested
- Toripalimab combined with oxaliplatin and Tegafur,Gimeracil and Oteracil Porassium Capsules
- Keywords
- Immunotherapy, Efficacy, Safety
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Toripalimab combined with oxaliplatin and Tegafur,Gimeracil and Oteracil Porassium CapsulesDrug
Toripalimab: 240mg IV Q3W;Tegafur,Gimeracil and Oteracil Porassium Capsules: 40mg/m2 Bid PO×14d Q3W;Oxaliplatin: 130mg/m2 IV Q3W
| Study group | Role | What they receive |
|---|---|---|
| Toripalimab combine CT | Experimental | Not described Receives: Drug: Toripalimab combined with oxaliplatin and Tegafur,Gimeracil and Oteracil Porassium Capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate
The percentage of patients whose tumors shrink to a certain extent and remain there for a certain period of time, including CR+PR cases
Measured: All subjects receive tumor assessment every 6 weeks until desease progress, up to 24mons. Objective response rate is defined as the date from ICF signation to the date of first documented progression or date of death from any cause, whichever came first.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2019
- Study start1 Feb 2020 (estimated)
- Primary completion1 Feb 2022 (estimated)
- Study completion1 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by RenJi 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04202484
- Sponsor's protocol ID
- ZLK-XXY-1
- Status last verified
- Dec 2019
- First submitted
- 5 Dec 2019
- Last updated
- 17 Dec 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-arm, Exploratory Clinical Research on the Efficacy and Safety of Tripletrumab Combined With Oxaliplatin and Teggio (SOX) in First-line Treatment of Unresectable Locally Advanced or Metastatic Gastric and Gastroesophageal Junction Adenocarcinoma
- ClinicalTrials.gov ID
- NCT04202484
- Acronym / sponsor ID
- ZLK-XXY-1
- Conditions
- Gastric Cancer
- Keywords
- Immunotherapy, Efficacy, Safety
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 1 Feb 2020 (estimated)
- Primary completion
- 1 Feb 2022 (estimated)
- Study completion
- 1 Feb 2023 (estimated)
- First posted
- 17 Dec 2019 (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.
The aim population is histopathologically confirmed locally unresectable advanced recurrent or metastatic adenocarcinoma of the gastric and gastroesophageal junction. Purpose of research to evaluate the efficacy and safety of tripletrumab combined with oxaliplatin and teggio (SOX) in first-line treatment of unreactable locally advanced, recurrent or metastatic gastric and gastroesophageal junction adenocarcinoma.
Every 21 days is a cycle, and treatment is scheduled for 6 cycles. Chemotherapy drugs until disease progression, toxicity intolerance, the start of new anti - tumor treatment, withdrawal, loss of access or death, etc., already reached first, shall be the basis for termination.
Treatment was effective for more than 6 treatment cycles and toxicity was, the subjects were judged by the researchers when to terminate the treatment and adjust the follow-up treatment plan.
For disease progression, toxicity intolerance, and initiation of new antitumor therapies.
For subjects who donot reach terminal events such as treatment, withdrawal, loss of follow-up or death, at the end of chemotherapy , the follow-up maintenance regimen was adjusted according to the researchers' evaluation.
The screening period of the study was 14 days. The screening test was completed and the evaluation was completed.
Subjects with standard discharge entered the treatment period, and the frequency of administration was determined according to the protocol.
Conduct treatment and complete relevant tests and assessments before each administration.
Tumor imaging was assessed every 6 weeks (±7 days) and all subjects were treated.
At the end of the visit, safety and imaging evaluations should be completed. Complete follow-up was conducted for a total of 90 days. Continue to receive tumor evaluation and imaging at a frequency of 2-3 months. Evaluation until disease progression, new antitumor therapy, withdrawal, Lost or dead, etc.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Toripalimab combine CT | Experimental | Drug: Toripalimab combined with oxaliplatin and Tegafur,Gimeracil and Oteracil Porassium Capsules |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18-80;
- Radiographic findings were consistent with non-resectable locally advanced, recurrent or metastatic gastric and gastroesophageal junction adenocarcinoma;
- Non-resectable locally advanced, recurrent or metastatic adenocarcinoma of the gastric and gastroesophageal junction (including sig-ring cell carcinoma and adhesion) confirmed by histopathological examination Liquid adenocarcinoma, hepatoid adenocarcinoma);
- ECOG 0-1;
- Adequate organ and bone marrow function, as defined below:
Key exclusion criteria (13 listed)
- Adenocarcinoma of the gastric and gastroesophageal junction diagnosed as HER2 positive; Previous exposure to any anti-pd-1 or anti-pd-l1, pd-l2, CD137, ctla-4 antibody therapy, or any other antibodies or drugs specifically targeting T cell co-stimulation or checkpoint pathways; Previous systematic treatment for advanced or metastatic adenocarcinoma of the gastric and gastroesophageal junction;
- Participate in another interventional clinical study, unless participating in an observational (non-interventional) clinical study or in the follow-up phase of the interventional study;
- Patients with autoimmune diseases or abnormal immune system;
- The history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation is known; uncontrolled high blood pressure, diabetes and heart disease;
- Cardia and pylorus are nearly obstructed, affecting the patient's eating and stomach emptying, or swallowing tablets is obstructed; The signs of lesion activity bleeding under endoscopy are known;
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 |
|---|---|---|
| Toripalimab combined with oxaliplatin and Tegafur,Gimeracil and Oteracil Porassium CapsulesToripalimab: 240mg IV Q3W;Tegafur,Gimeracil and Oteracil Porassium Capsules: 40mg/m2 Bid PO×14d Q3W;Oxaliplatin: 130mg/m2 IV Q3W | Drug | Toripalimab combine CT |
Primary outcome
Objective Response Rate
Time frame: All subjects receive tumor assessment every 6 weeks until desease progress, up to 24mons. Objective response rate is defined as the date from ICF signation to the date of first documented progression or date of death from any cause, whichever came first.
The percentage of patients whose tumors shrink to a certain extent and remain there for a certain period of time, including CR+PR cases
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2019.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Toripalimab combined with oxaliplatin and Tegafur,Gimeracil and Oteracil Porassium Capsules in people with Gastric Cancer, run by RenJi Hospital.
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 6 inclusion and 13 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 17 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Xiuying Xiao, doc (13564579313, xiaoxiuying2002@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (time frame: All subjects receive tumor assessment every 6 weeks until desease progress, up to 24mons. Objective response rate is defined as the date from ICF signation to the date of first documented progression or date of death from any cause, whichever came first.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Dec 2019.