TislelizumabNCT06034964
Tislelizumab Combined With Chemotherapy in First-line Treatment of AGC
An observational study of Tislelizumab and Chemotherapy, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
This is a single-center, retrospective clinical study to evaluate the efficacy and safety of tislelizumab combined with first-line chemotherapy in the treatment of HER2-negative advanced gastric cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tislelizumab, Chemotherapy, First-line
- What is being tested?
- Tislelizumab
- Type of treatment
- Injection or infusion
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2020to 1 Nov 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: HER-2 negative, untreated patients with advanced gastric cancer.
Who may be able to join
- Patients with initially unresectable (locally advanced or metastatic) or postoperative recurrence of gastric adenocarcinoma or gastroesophageal junction adenocarcinoma confirmed by histopathology have not received any anti-tumor treatment for advanced gastric cancer in the past;
- Pathological immunohistochemistry or FISH detection of gastric cancer tissue indicates negative Her-2;
- Age range from 18 to 70 years old, regardless of gender;
- The distance between postoperative recurrence and the end of neoadjuvant/adjuvant chemotherapy is more than 6 months;
- If the patient experiences toxic side effects after receiving new adjuvant/adjuvant treatment, they need to recover from previous treatment toxic side effects to ≤ 1 level; According to the RECIST evaluation criteria, there should be at least one assessable lesion. Expected survival time ≥ 3 months;
- 7. ECOG score ≤ 2 points; 8. Main organ functions are basically normal, blood count (within 7 days): hemoglobin ≥ 90g/L, white blood cells ≥ 4.0 × 109/L, neutrophils ≥ 2.0 × 109/L, platelet ≥ 100.0 × 109/L. Total bilirubin 1.0 UNL, creatinine 1.0 × UNL, AST/ALT 2.5 UNL. Liver metastasis: ASAT/ALAT 5 UNL; 9. The electrocardiogram/cardiac function tests are basically normal.
Who cannot join
- Suffering from undifferentiated gastric cancer or squamous cell carcinoma of the gastroesophageal junction and other pathological types of malignant tumors;
- Have received anti-tumor treatment for gastric adenocarcinoma or adenocarcinoma at the junction of stomach and esophagus that can not be operated on for the first time or recur after operation, including but not limited to chemotherapy, Targeted therapy, immunotherapy, etc. (except for Thymosin and traditional Chinese medicine treatment);
- Patients with other primary malignant tumors other than gastric cancer, excluding cured skin Basal-cell carcinoma and cervical Carcinoma in situ;
- Patients with simple or combined brain metastasis;
- Has experienced gastrointestinal perforation or fistula within 6 months prior to enrollment;
- Patients who also suffer from other important organ diseases, including severe heart disease;
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- Complications such as uncontrollable moderate to massive ascites, active gastrointestinal bleeding, gastrointestinal perforation, gastrointestinal obstruction, etc;
- Patients with chronic diseases such as hypertension, hyperglycemia, and COPD that are difficult to control;
- Those who require antibiotics for systemic anti infection, active hepatitis, active pulmonary tuberculosis, and other diseases.
Trial locations and contacts
1 site in 1 country.
China1 site
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing
About this study
Official title: Retrospective Study of Tislelizumab Combined With Chemotherapy in First-line Treatment of HER2-negative Advanced Gastric Cancer
This is a single-center, retrospective clinical study to evaluate the efficacy and safety of tislelizumab combined with first-line chemotherapy in the treatment of HER2-negative advanced gastric cancer.
Read the detailed description
This study aims to include 60 HER-2 negative advanced gastric cancer patients who received first-line treatment with tislelizumab combined with chemotherapy in our hospital from November 1, 2020 to November 1, 2021. Clinicopathological data, blood tests and imaging data of the patients were collected. The primary endpoints evaluated were PFS and OS, and the secondary endpoints were ORR and safety. At the same time, ctDNA and peripheral cytokine status of patients as well as second-generation sequencing of tumor tissues at baseline were collected for the exploration of therapeutic efficacy related biomarkers.
- Conditions
- Tislelizumab, Chemotherapy, First-line, Gastric Cancer Stage IV
- Being tested
- Tislelizumab
- Keywords
- Tislelizumab, First-line, Gastric cancer
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TislelizumabDrug
Also called BGB-A317
Tislelizumab：200mg, iv, d1, 21 days per cycle, until disease progression or intolerable toxicity
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
Progression-free Survival
Measured: 2 years
OS
Overall Survival
Measured: 3 years
Secondary outcomes (4)
ORR
Objective Remission Rate
Measured: 2 years
DCR
Disease Control Rate
Measured: 2 years
DOR
Duration of Remission
Measured: 2 years
Safety and Tolerability
Incidence of Treatment-Emergent Adverse Events
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start1 Nov 2020
- Primary completion1 Nov 2022
- Study completion1 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TislelizumabStudies of the same condition, open and under way.
- More trials run by Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lin Yang, Principal investigator, Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06034964
- Sponsor's protocol ID
- NCC3221
- Status last verified
- Aug 2023
- First submitted
- 6 Sep 2023
- Last updated
- 13 Sep 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Study of Tislelizumab Combined With Chemotherapy in First-line Treatment of HER2-negative Advanced Gastric Cancer
- ClinicalTrials.gov ID
- NCT06034964
- Acronym / sponsor ID
- NCC3221
- Conditions
- Tislelizumab, Chemotherapy, First-line, Gastric Cancer Stage IV
- Keywords
- Tislelizumab, First-line, Gastric cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 1 Nov 2022 (actual)
- Study completion
- 1 Nov 2025 (estimated)
- First posted
- 13 Sep 2023 (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 single-center, retrospective clinical study to evaluate the efficacy and safety of tislelizumab combined with first-line chemotherapy in the treatment of HER2-negative advanced gastric cancer.
Detailed description
This study aims to include 60 HER-2 negative advanced gastric cancer patients who received first-line treatment with tislelizumab combined with chemotherapy in our hospital from November 1, 2020 to November 1, 2021. Clinicopathological data, blood tests and imaging data of the patients were collected. The primary endpoints evaluated were PFS and OS, and the secondary endpoints were ORR and safety. At the same time, ctDNA and peripheral cytokine status of patients as well as second-generation sequencing of tumor tissues at baseline were collected for the exploration of therapeutic efficacy related biomarkers.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HER-2 negative, untreated patients with advanced gastric cancer.
Key inclusion criteria (6 listed)
- Patients with initially unresectable (locally advanced or metastatic) or postoperative recurrence of gastric adenocarcinoma or gastroesophageal junction adenocarcinoma confirmed by histopathology have not received any anti-tumor treatment for advanced gastric cancer in the past;
- Pathological immunohistochemistry or FISH detection of gastric cancer tissue indicates negative Her-2;
- Age range from 18 to 70 years old, regardless of gender;
- The distance between postoperative recurrence and the end of neoadjuvant/adjuvant chemotherapy is more than 6 months;
- If the patient experiences toxic side effects after receiving new adjuvant/adjuvant treatment, they need to recover from previous treatment toxic side effects to ≤ 1 level; According to the RECIST evaluation criteria, there should be at least one assessable lesion. Expected survival time ≥ 3 months;
Key exclusion criteria (9 listed)
- Suffering from undifferentiated gastric cancer or squamous cell carcinoma of the gastroesophageal junction and other pathological types of malignant tumors;
- Have received anti-tumor treatment for gastric adenocarcinoma or adenocarcinoma at the junction of stomach and esophagus that can not be operated on for the first time or recur after operation, including but not limited to chemotherapy, Targeted therapy, immunotherapy, etc. (except for Thymosin and traditional Chinese medicine treatment);
- Patients with other primary malignant tumors other than gastric cancer, excluding cured skin Basal-cell carcinoma and cervical Carcinoma in situ;
- Patients with simple or combined brain metastasis;
- Has experienced gastrointestinal perforation or fistula within 6 months prior to enrollment;
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 |
|---|---|---|
| TislelizumabAlso: BGB-A317Tislelizumab：200mg, iv, d1, 21 days per cycle, until disease progression or intolerable toxicity | Drug | – |
Primary outcome
PFS
Time frame: 2 years
Progression-free Survival
OS
Time frame: 3 years
Overall Survival
4 secondary outcomes
ORR
Time frame: 2 years
DCR
Time frame: 2 years
DOR
Time frame: 2 years
Safety and Tolerability
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
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RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
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RecruitingPhase 2
Perioperative Chemotherapy With Low-Dose Radiotherapy and Tislelizumab for Locally Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
Gastric or Gastroesophageal Junction Adenocarcinoma
RecruitingPhase 3
Clinical Trial of N-803 Plus Tislelizumab or Prior Failed Immune Checkpoint Inhibitor and Docetaxel Versus Docetaxel Monotherapy in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Acquired Resistance to Immune Checkpoint Inhibitor Therapy
NSCLC Stage IV
RecruitingPhase 3
A Study Comparing QLC5508 in Combination With QL2107 Versus Tislelizumab Plus Platinum-based Chemotherapy in Participants Wih Treatment-naïve Extensive-Stage Small Cell Lung Cancer
Extensive-stage Small Cell Lung Cancer
RecruitingPhase 3
A Study Comparing BL-B01D1 Combined With Tislelizumab Versus Platinum-containing Chemotherapy Combined With Tislelizumab as First-line Treatment in Patients With Extensive-stage Small Cell Lung Cancer(PANKU-Lung07)
Extensive-stage Small-cell Lung Cancer
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.
Lin Yang principal investigator
Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
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 Tislelizumab and Chemotherapy, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences 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 6 inclusion and 9 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 13 Sep 2023. 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?
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?
PFS (time frame: 2 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?
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 13 Sep 2023.