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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04098796
|Contact: Qian Dongemail@example.com|
|Liaoning Cancer Hospital & Institute||Recruiting|
|Shenyang, Liaoning, China, 110042|
|Contact: Qian Dong, Doctor 17309815028 firstname.lastname@example.org|
|Principal Investigator: Jingdong Zhang, Doctor|
|Principal Investigator:||Jingdong Zhang||China Medical University, China|