Gastric or Gastroesophageal Junction AdenocarcinomaPhase 2NCT04098796
PD-1 Antibody + XELOX in 1st Line Serum A-fetoprotein (AFP)-Elevated Gastric or Gastroesophageal Junction Adenocarcinoma
A Phase 2 study testing Anti-PD-1 antibody and XELOX in people with Gastric or Gastroesophageal Junction Adenocarcinoma and AFP, run by China Medical University, China at 1 site in China.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of of anti-PD-1 antibody in combination with chemotherapy as first-line treatment in patients with unresectable, locally advanced recurrent or metastatic serum AFP-elevated gastric and gastroesophageal junction adenocarcinoma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric or Gastroesophageal Junction Adenocarcinoma, AFP
- What is being tested?
- Anti-PD-1 antibody and XELOX
- 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 Oct 2019to 30 Sep 2021
- 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
- Patients must volunteer to participate in the study, signed informed consent, and were able to comply with the program requirements of visits and related procedures.
- Age and gender: ≥18 years old and≤75 years old, both men and women.
- All subjects must have unresectable, local advanced recurrent or metastatic gastric adenocarcinoma (GC) or gastroesophageal junction adenocarcinoma (GEC) confirmed by histologically.
- No systematic treatment for advanced or metastatic GC/GEC has been received in the past. For patients who have received adjuvant or neoadjuvant therapy (including chemotherapy, radiotherapy and/or radiochemotherapy) for GC/GEC in the past, the last treatment must be completed at least six months before the start of study drug. Subjects are allowed to receive palliative radiotherapy, but it must be completed two weeks before the start of study drug.
- Serum AFP > 20 ng/ml.
- All acute toxic reactions caused by previous medication or surgery were alleviated to grade 0-1 (according to NCI-CTCAE version 5.0) or to the level specified by the criteria for Inclusion/exclusion. The toxicities that do not pose a safety risk to patients determined by investigators are excluded, such as hair loss , etc.
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- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
- Expected survival: ≥12 weeks.
- Subject must have at least one measurable lesion or evaluable disease by CT or MRI per RECIST 1.1 criteria.
- The functions of important organs must meet the following requirements:(1)Hematological system: Neutrophil count≥1.5×10^9/L; Platelet count≥80×10^9/L; Hemoglobin≥90g/L;(2)Liver function: Serum albumin≥28g/L; Total bilirubin (TBI)≤1.5×ULN; Alanine aminotransferase (ALT)≤2.5×ULN (or≤5×ULN if liver metastases are present); Aspartate aminotransferase (AST)≤2.5×ULN (or≤5×ULN if liver metastases are present); (3)Renal function: Serum creatinine≤1.5×ULN or calculated creatinine clearance (CrCl) ≥40 mL/min (using the Cockcroft-Gault formula):Female CrCl = (140- age in years) × weight in kg × 0.85/ 72 × serum creatinine in mg/ dL; Male CrCl = (140- age in years) × weight in kg × 1.00/72 × serum creatinine in mg/ dL;(4)Coagulation function: Subjects not receiving anticoagulation therapy: (International Normalized Ratio) INR or activeated partial thromboplastin time (APTT) ≤ 1.5×ULN.
- Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test within 7 days prior to the start of study drug. WOCBP must agree to follow instructions for method(s) of contraception (e.g. intrauterine devices, contraceptives, condoms or abstinence) for the duration of study treatment and 6 months after the last dose of study treatment. Subjects must be non-lactating. Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of study treatment and 6 months after the last dose of study treatment.
Who cannot join
- Known human epidermalgrowth factor receptor-2 (HER2) positive.
- Currently participating in research and receiving research treatment, or participating in the research of experimental drugs within four weeks before the start of study drug, and having received research treatment or used experimental instruments.
- Major surgery were performed within 4 weeks before the start of the study and incomplete recovery.
- Existence of any active autoimmune disease or with a history of autoimmune disease (as the following examples, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary, vasculitis, nephritis, hyperthyroidism; patients with vitiligo; in childhood asthma has been completely alleviated, adults without any intervention can be included; asthma with medical intervention could not be included). Substitution therapy is not considered as systemic therapy. Patients with the following diseases are not excluded and may proceed to further screening: a. Controlled Type I diabetes; b. Hypothyroidism (provided it is managed with hormone replacement therapy only).
- Any condition that required systemic treatment with either corticosteroids (> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication ≤ 7 days before randomization.
- Any active malignancy ≤ 5 years before randomization except for the specific cancer under investigation in this study and any cured limited tumors (eg, carcinoma in situ of the cervix or prostate, basal cell skin cancer).
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- Patients with known central nervous system metastasis (suspected need to be excluded by MRI scans) or a history of hepatic encephalopathy.
- A history of pneumonia (non-infectious) requiring steroid therapy within 6 months or currently suffering from pneumonia (pulmonary infectious).
- With active infections, fever of unknown origin (≥38.5℃) within 7 days before the start of study drug; or white blood cell count at baseline > 15×10^9/L); with severe chronic or active infections (including tuberculosis infection, etc.) requiring systemic antibacterial, antifungal or antiviral therapy during screening period, excluding viral hepatitis.
- With any other disease, metabolic abnormality, abnormal physical examination or abnormal laboratory examination, according to the judgments of the investigators, there is reason to suspect that the patient has a certain disease or condition that is not suitable for the use of study drugs, or that it will affect the interpretation of research results or put the patient at high risk.
- Mental or drug abuse disorders known to have an impact on compliance with study requirements
- Congenital or acquired immunodeficiency (e.g. HIV-infected persons).
- With active hepatitis B virus (HBV) or hepatitis C virus (HCV). Active hepatitis B is defined as known positive HBsAg results, and HBV-DNA > 2000IU/ml. Active hepatitis C is defined as known positive hepatitis C antibodies and the quantitative results of HCV RNA are higher than the lower detection limit of analytical methods. Active HBV will be allowed if they have HBV DNA < 500 IU/mL (or 2500 copies/mL) at screening. Patients with HBV-DNA < 2000IU/ml through antiviral therapy can be considered included.
- Was administered a live attenuated vaccine ≤ 4 weeks before randomization, or plan to vaccinate during treatment with against PD-1 monoclonal antibody or within five months after last administration.
- More than a small amount of pericardial effusion, uncontrolled pleural effusion or clinically obvious peritoneal effusion at screening. It is defined as meeting the following criteria: physical examination at screening can detect pleural and peritoneal effusion, or in screening process, pleural and peritoneal effusion needs puncture and drainage.
- With history of serious cardiovascular and cerebrovascular diseases: (1) Any history of heart failure meeting New York Heart Association Classification III or IV or more serious history of heart disease, myocardial infarction, or cerebrovascular accident in 3 months before randomization；(2) Left ventricular ejection fraction < 50% by color Doppler echocardiography；(3) Uncontrollable hypertension; (4) Uncontrolled arrhythmias; (5) Acute coronary syndrome, congestive heart failure, stroke, thromboembolism or other cardiovascular events above grade 3 within 6 months before the start of study drug.
- A history of allergy to anti-PD-1, anti-PD-L1 monoclonal antibody drugs or oxaliplatin or capecitabine.
- Known dihydropyrimidine dehydrogenase deficiency.
- Pregnant or lactating women; or female subjects who are expected to conceive during the planned trial period (from the start of screening visits to 120 days after the last administration of the study) or male subjects whose spouses are pregnant.
- Other situations that the researchers think should be excluded.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Liaoning Cancer Hospital & Institute
Shenyang, Liaoning, 110042
Qian Dong, Doctor, 17309815028, dongqian08@163.com
Jingdong Zhang, Doctor
About this study
Official title: Anti-PD-1 Antibody Combined With Chemotherapy as First-line Treatment of Serum AFP-elevated Gastric or Gastroesophageal Junction Adenocarcinoma: a Single-arm, Multicenter Phase II Study
The purpose of this study is to evaluate the efficacy and safety of of anti-PD-1 antibody in combination with chemotherapy as first-line treatment in patients with unresectable, locally advanced recurrent or metastatic serum AFP-elevated gastric and gastroesophageal junction adenocarcinoma.
Read the detailed description
AFP-elevated gastric adenocarcinoma is a special type of gastric cancer, with the characteristics of high risk of liver and lymph node metastasis, poor therapeutic effect, and dismal prognosis.
This prospective study is a single-arm, multicenter phase II clinical study to evaluate the efficacy and safety of anti-PD-1 antibody in combination with chemotherapy as first-line treatment in patients with unresectable, locally advanced recurrent or metastatic serum AFP-elevated gastric and gastroesophageal junction adenocarcinoma.
AFP elevation is defined as serum AFP > 20 ng/ml. In this prospective study, the objective remission rate (ORR) will be used as primary outcome measures and 30 patients will be recruited. Anti-PD-1 antibody in combination with chemotherapy will be administered. PD-L1 expression and tumor mutant burden (TMB) will be measured before treatment. In addition, the dynamic changes of serum AFP levels, T lymphocyte in peripheral blood will be monitored during treatment. In the course of treatment, safety evaluation will be carried out according to the standard of adverse reaction classification (CTCAE) 4.0.
- Being tested
- Anti-PD-1 antibody, XELOX
- Keywords
- Gastric or gastroesophageal junction adenocarcinoma, AFP, PD-1, chemotherapy, first-line
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-PD-1 antibodyDrug
Sintilimab will be administered 200 mg intravenous drip, every 3 weeks. Anti-PD-1 antibody will be administered until the disease progresses or lasts for two years.
XELOXDrug
Oxaliplatin 130 mg/m2, intravenous drip, d 1; Capecitabine 1000mg/ kg, twice a day, orally, d1-14; Every 21 days. XELOX 6-8cycles，followed by capecitabine monotherapy, the course of treatment is determined by the investigators according to clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Anti-PD-1 antibody＋XELOX | Experimental | Every patient will receive anti-PD-1 antibody (200 mg intravenous drip every 3 weeks) and XELOX regimen chemotherapy (Oxaliplatin 130 mg/m2, intravenous drip, d1; Capecitabine 1000mg/ kg, twice a day, orally, d1-14;every 21 days). Anti-PD-1 antibody will be administered until the disease progresses or lasts for two years. XELOX will be administered 6-8cycles，followed by capecitabine monotherapy, the course of treatment is determined by the investigators according to clinical practice. Receives: Drug: Anti-PD-1 antibody; Drug: XELOX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
The proportion of patients whose best overall response (BOR) is complete response (CR) or partial response (PR) assessed by RECIST v1.1.
Measured: 2 years
Secondary outcomes (8)
Progression-free survival (PFS)
The time from the date of randomization to the date of first documentation of disease progression or death, whichever occurs first.
Measured: 2 years
Overall survival (OS)
The time from the date of randomization until the date of death due to any cause.
Measured: 2 years
Duration of response (DOR)
The time from CR or PR to disease progression or death.
Measured: 2 years
Disease control rate (DCR)
The proportion of patients who's BOR is CR, PR, and stable disease (SD) assessed.
Measured: 2 years
6-month/9-month/12-month survival rate
After date of randomization, evaluate patient survival rate at 6,9 and 12 months, respectively.
Measured: 6-month/9-month/12-month
Incidence of Treatment-Emergent Adverse Events
Incidence of Treatment-Emergent Adverse Events.The grade of toxicity will be assessed using the NCI-CTCAE version 5.0.
Measured: 2 years
Quality of life score (QLQ-C30)
Scores according to the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 scoring manual.
Measured: Every 2 weeks after the first treatment until 2 years
Exploration of biomarkers (PD-L1 expression, TMB at the baseline, changes of AFP and T lymphocyte in peripheral blood)
PD-L1 expression at the baseline using, TMB level at the baseline, changes of serum AFP level and T lymphocyte in peripheral blood at baseline and during the treatment，and etc.
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 posted23 Sep 2019
- Study start1 Oct 2019
- Primary completion30 Sep 2021 (estimated)
- Study completion30 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric or Gastroesophageal Junction AdenocarcinomaStudies of the same condition, open and under way.
- 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 (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jingdong Zhang, China Medical University, China
- Investigators
- Jingdong Zhang, Principal investigator, China Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04098796
- Sponsor's protocol ID
- PD-1-CT-Ⅱ-1st L-AFPGC
- Status last verified
- Apr 2021
- First submitted
- 19 Sep 2019
- Last updated
- 14 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti-PD-1 Antibody Combined With Chemotherapy as First-line Treatment of Serum AFP-elevated Gastric or Gastroesophageal Junction Adenocarcinoma: a Single-arm, Multicenter Phase II Study
- ClinicalTrials.gov ID
- NCT04098796
- Acronym / sponsor ID
- PD-1-CT-Ⅱ-1st L-AFPGC
- Keywords
- Gastric or gastroesophageal junction adenocarcinoma, AFP, PD-1, chemotherapy, first-line
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- China Medical University, ChinaUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 30 Sep 2021 (estimated)
- Study completion
- 30 Sep 2021 (estimated)
- First posted
- 23 Sep 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 purpose of this study is to evaluate the efficacy and safety of of anti-PD-1 antibody in combination with chemotherapy as first-line treatment in patients with unresectable, locally advanced recurrent or metastatic serum AFP-elevated gastric and gastroesophageal junction adenocarcinoma.
Detailed description
AFP-elevated gastric adenocarcinoma is a special type of gastric cancer, with the characteristics of high risk of liver and lymph node metastasis, poor therapeutic effect, and dismal prognosis.
This prospective study is a single-arm, multicenter phase II clinical study to evaluate the efficacy and safety of anti-PD-1 antibody in combination with chemotherapy as first-line treatment in patients with unresectable, locally advanced recurrent or metastatic serum AFP-elevated gastric and gastroesophageal junction adenocarcinoma.
AFP elevation is defined as serum AFP > 20 ng/ml. In this prospective study, the objective remission rate (ORR) will be used as primary outcome measures and 30 patients will be recruited. Anti-PD-1 antibody in combination with chemotherapy will be administered. PD-L1 expression and tumor mutant burden (TMB) will be measured before treatment. In addition, the dynamic changes of serum AFP levels, T lymphocyte in peripheral blood will be monitored during treatment. In the course of treatment, safety evaluation will be carried out according to the standard of adverse reaction classification (CTCAE) 4.0.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: Anti-PD-1 antibody＋XELOX | Experimental | Drug: Anti-PD-1 antibody, Drug: XELOXEvery patient will receive anti-PD-1 antibody (200 mg intravenous drip every 3 weeks) and XELOX regimen chemotherapy (Oxaliplatin 130 mg/m2, intravenous drip, d1; Capecitabine 1000mg/ kg, twice a day, orally, d1-14;every 21 days). Anti-PD-1 antibody will be administered until the disease progresses or lasts for two years. XELOX will be administered 6-8cycles，followed by capecitabine monotherapy, the course of treatment is determined by the investigators according to clinical practice. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients must volunteer to participate in the study, signed informed consent, and were able to comply with the program requirements of visits and related procedures.
- Age and gender: ≥18 years old and≤75 years old, both men and women.
- All subjects must have unresectable, local advanced recurrent or metastatic gastric adenocarcinoma (GC) or gastroesophageal junction adenocarcinoma (GEC) confirmed by histologically.
- No systematic treatment for advanced or metastatic GC/GEC has been received in the past. For patients who have received adjuvant or neoadjuvant therapy (including chemotherapy, radiotherapy and/or radiochemotherapy) for GC/GEC in the past, the last treatment must be completed at least six months before the start of study drug. Subjects are allowed to receive palliative radiotherapy, but it must be completed two weeks before the start of study drug.
- Serum AFP > 20 ng/ml.
Key exclusion criteria (20 listed)
- Known human epidermalgrowth factor receptor-2 (HER2) positive.
- Currently participating in research and receiving research treatment, or participating in the research of experimental drugs within four weeks before the start of study drug, and having received research treatment or used experimental instruments.
- Major surgery were performed within 4 weeks before the start of the study and incomplete recovery.
- Existence of any active autoimmune disease or with a history of autoimmune disease (as the following examples, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary, vasculitis, nephritis, hyperthyroidism; patients with vitiligo; in childhood asthma has been completely alleviated, adults without any intervention can be included; asthma with medical intervention could not be included). Substitution therapy is not considered as systemic therapy. Patients with the following diseases are not excluded and may proceed to further screening: a. Controlled Type I diabetes; b. Hypothyroidism (provided it is managed with hormone replacement therapy only).
- Any condition that required systemic treatment with either corticosteroids (> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication ≤ 7 days before randomization.
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 |
|---|---|---|
| Anti-PD-1 antibodySintilimab will be administered 200 mg intravenous drip, every 3 weeks. Anti-PD-1 antibody will be administered until the disease progresses or lasts for two years. | Drug | Experimental: Anti-PD-1 antibody＋XELOX |
| XELOXOxaliplatin 130 mg/m2, intravenous drip, d 1; Capecitabine 1000mg/ kg, twice a day, orally, d1-14; Every 21 days. XELOX 6-8cycles，followed by capecitabine monotherapy, the course of treatment is determined by the investigators according to clinical practice. | Drug | Experimental: Anti-PD-1 antibody＋XELOX |
Primary outcome
Objective response rate (ORR)
Time frame: 2 years
The proportion of patients whose best overall response (BOR) is complete response (CR) or partial response (PR) assessed by RECIST v1.1.
8 secondary outcomes
Progression-free survival (PFS)
Time frame: 2 years
Overall survival (OS)
Time frame: 2 years
Duration of response (DOR)
Time frame: 2 years
Disease control rate (DCR)
Time frame: 2 years
6-month/9-month/12-month survival rate
Time frame: 6-month/9-month/12-month
Incidence of Treatment-Emergent Adverse Events
Time frame: 2 years
Quality of life score (QLQ-C30)
Time frame: Every 2 weeks after the first treatment until 2 years
Exploration of biomarkers (PD-L1 expression, TMB at the baseline, changes of AFP and T lymphocyte in peripheral blood)
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 14 Apr 2021.
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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.
Jingdong Zhang principal investigator
China Medical University, China
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 Anti-PD-1 antibody and XELOX in people with Gastric or Gastroesophageal Junction Adenocarcinoma and AFP, run by China Medical University, China 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 11 inclusion and 20 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 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.
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 Qian Dong (17309815028, dongqian08@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 (ORR) (time frame: 2 years). 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 14 Apr 2021.