PD-1 Antibody + XELOX in 1st Line Serum A-fetoprotein (AFP)-Elevated Gastric or Gastroesophageal Junction Adenocarcinoma
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|ClinicalTrials.gov Identifier: NCT04098796|
Recruitment Status : Recruiting
First Posted : September 23, 2019
Last Update Posted : February 11, 2020
|Condition or disease||Intervention/treatment||Phase|
|Gastric or Gastroesophageal Junction Adenocarcinoma AFP||Drug: Anti-PD-1 antibody Drug: XELOX||Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||October 1, 2019|
|Estimated Primary Completion Date :||September 30, 2020|
|Estimated Study Completion Date :||September 30, 2021|
Experimental: Experimental: Anti-PD-1 antibody＋XELOX
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.
Drug: Anti-PD-1 antibody
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.
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.
- 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.
- Progression-free survival (PFS) [ Time Frame: 2 years ]The time from the date of randomization to the date of first documentation of disease progression or death, whichever occurs first.
- Overall survival (OS) [ Time Frame: 2 years ]The time from the date of randomization until the date of death due to any cause.
- Duration of response (DOR) [ Time Frame: 2 years ]The time from CR or PR to disease progression or death.
- Disease control rate (DCR) [ Time Frame: 2 years ]The proportion of patients who's BOR is CR, PR, and stable disease (SD) assessed.
- 6-month/9-month/12-month survival rate [ Time Frame: 6-month/9-month/12-month ]After date of randomization, evaluate patient survival rate at 6,9 and 12 months, respectively.
- Incidence of Treatment-Emergent Adverse Events [ Time Frame: 2 years ]Incidence of Treatment-Emergent Adverse Events.The grade of toxicity will be assessed using the NCI-CTCAE version 5.0.
- Quality of life score (QLQ-C30) [ Time Frame: Every 2 weeks after the first treatment until 2 years ]Scores according to the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 scoring manual.
- Exploration of biomarkers (PD-L1 expression, TMB at the baseline, changes of AFP and T lymphocyte in peripheral blood) [ Time Frame: 2 years ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04098796
|Contact: Qian Dongfirstname.lastname@example.org|
|Liaoning Cancer Hospital & Institute||Recruiting|
|Shenyang, Liaoning, China, 110042|
|Contact: Qian Dong, Doctor 17309815028 email@example.com|
|Principal Investigator: Jingdong Zhang, Doctor|
|Principal Investigator:||Jingdong Zhang||China Medical University, China|