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Select Ongoing Trials Currently Enrolling Patients with Esophageal Cancer

April 2023, Vol 13, No 4

The following clinical trials represent a selection of key studies currently recruiting patients with esophageal cancer for inclusion in investigations of new therapies and new regimens of existing treatments for the disease. Each clinical trial description includes the NLM Identifier to be used as a reference with ClinicalTrials.gov. This information can help oncology practice managers and providers direct eligible patients to one of these trials.


1. Atezolizumab with or without Tiragolumab in Unresectable ESCC

The purpose of this randomized, double-blind, placebo-controlled, phase 3 trial is to evaluate the efficacy and safety of atezolizumab (Tecentriq) with or without tiragolumab (MTIG7192A) versus placebo as treatment for patients with unresectable esophageal squamous-cell carcinoma (ESCC) whose disease has not progressed after definitive concurrent chemotherapy. Patients aged ≥18 years with histologically or cytologically confirmed ESCC that is ineligible for curative surgery, who have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, and who have received definitive concurrent chemotherapy according to oncology guidelines for esophageal cancer may be eligible if other criteria are met. Eligible patients will be randomized to receive either intravenous (IV) atezolizumab 1200 mg and tiragolumab 600 mg IV every 3 weeks on day 1 of each 21-day cycle; atezolizumab 1200 mg IV and tiragolumab placebo; or atezolizumab placebo and tiragolumab placebo.

The primary outcome measures include investigator-assessed progression-free survival (PFS) and overall survival (OS) from randomization to first occurrence of disease progression or death from any cause, for up to approximately 50 months. Secondary outcome measures include independent review facility-assessed PFS, investigator-assessed confirmed objective response rate (ORR), duration of response (DOR), the percentage of patients with adverse events (AEs), and the percentage of patients with clinically meaningful changes in physical functioning, role functioning, and quality of life per the European Organisation for Research and Treatment of Cancer Quality of Life-Core 30 Questionnaire (EORTC QLQ-C30). The study plans to enroll approximately 750 participants throughout the United States and worldwide. For more information, contact Hoffmann-La Roche at 1-888-662-6728 or This email address is being protected from spambots. You need JavaScript enabled to view it., and mention reference ID number YO42137. The NLM identifier is NCT04543617.


2. Adding Radiotherapy to Usual Chemotherapy in Oligometastatic, HER2-Negative Esophageal and Gastric Adenocarcinoma

The purpose of this randomized, open-label, phase 3 study is to evaluate the efficacy of adding radiotherapy to standard-of-treatment chemotherapy (FOLFOX [5-fluorouracil {5-FU}, leucovorin calcium, and oxaliplatin] or CAPOX [capecitabine and oxaliplatin]) versus chemotherapy alone as treatment for patients with oligometastatic, HER2-negative esophageal and gastric adenocarcinoma whose disease has not progressed on first-line therapy. Patients aged ≥18 years with confirmed HER2-negative, oligometastatic disease at the time of registration for the induction phase, who have an ECOG performance status of 0 or 1, whose disease is stable after approximately 4 months of FOLFOX or 6 months of CAPOX in the induction phase, and who have no evidence of disease progression based on RECIST version 1.1 since the induction phase may be eligible if other criteria are met. Eligible patients will be randomized to 1 of 4 arms after the induction phase: radiation therapy plus FOLFOX, FOLFOX alone, radiation therapy plus CAPOX, or CAPOX alone.

The primary outcome measure is OS from the time of randomization, assessed up to 5 years after treatment. Secondary outcome measures include the incidence of AEs, graded by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, and PFS from time of randomization up to 5 years after treatment. The study plans to enroll 314 participants throughout the United States and worldwide. For more information, contact Nataliya V. Uboha at the ECOG-ACRIN Cancer Research Group at 1-608-265-9966 or This email address is being protected from spambots. You need JavaScript enabled to view it.. The NLM identifier is NCT04248452.


3. Definitive Chemoradiation with or without Durvalumab in Locally Advanced, Unresectable ESCC

The purpose of this randomized, double-blind, placebo-controlled, multicenter, international, phase 3 study is to assess the efficacy and safety of durvalumab (Imfinzi) administered concurrently with definitive chemoradiation (CRT) as treatment for patients with ESCC. Patients aged ≥18 years with histologically or cytologically confirmed locally advanced ESCC whose disease is unresectable and is suitable for definitive CRT therapy, who have an ECOG performance status of 0 or 1, who have a life expectancy of >3 months, and who have adequate organ and marrow function may be eligible if other criteria are met. Eligible patients will be randomized in a 2:1 ratio to receive either durvalumab plus definitive CRT or placebo plus definitive CRT.

The primary outcome measure is PFS per RECIST version 1.1 as assessed by blinded independent central review in all randomized patients and in patients with PD-L1–high tumors until disease progression. The secondary outcome measure is OS in all patients and in patients with PD-L1–high tumors until the date of death, and other outcome measures are AEs to assess the safety and tolerability of durvalumab plus definitive CRT versus placebo plus CRT. The study plans to enroll 600 participants throughout the United States and worldwide. For more information, contact the AstraZeneca Clinical Study Information Center at 1-877-240-9479 or This email address is being protected from spambots. You need JavaScript enabled to view it.. The NLM identifier is NCT04550260.


4. Proton Beam Therapy versus Intensity Modulated Photon Radiotherapy in Stage I-IVA Esophageal Cancer

The purpose of this randomized, open-label, phase 3 trial is to study the efficacy of proton beam therapy (PBT) versus intensity modulated photon radiotherapy (IMRT) with chemotherapy (carboplatin plus paclitaxel, FOLFOX/CAPOX, or docetaxel and 5-FU or capecitabine) and esophagectomy as treatment for patients with stage I-IVA esophageal cancer. Patients aged ≥18 years with histologically confirmed stage I-IVA adenocarcinoma or squamous-cell carcinoma of the thorax or esophagus or gastroesophageal junction (GEJ); with a Zubrod performance status of 0-2; who have had a surgical consultation to determine candidacy for resection after completion of CRT; and who have had FOLFOX induction chemotherapy prior to concurrent CRT if last dose is no more than 90 days and less than 10 days before registration, may be eligible if other criteria are met. Eligible patients will be randomized to receive PBT or IMRT over 28 fractions 5 days a week for 5.5 weeks for a total dose of 50.4 Gy, plus choice of chemotherapy, and esophagectomy per physician discretion within 4-8 weeks after completion of chemotherapy and radiation therapy.

The primary outcome measures are OS from the date of randomization to the date of death due to any cause or date of last follow-up for patients without an OS event reported, and the incidence of specific grade ≥3 cardiopulmonary AEs per NCI CTCAE version 5.0. Secondary outcome measures include pathologic response rate, PFS, grade 4 lymphopenia during CRT, lymphocyte counts, locoregional failure, distant metastatic-free survival, quality-adjusted life-years, and the cost–benefit economic analysis of treatment. The study plans to enroll 300 participants throughout the United States. For more information, contact the recruiting sites directly. The NLM identifier is NCT03801876.


5. Sintilimab versus Placebo in Combination with Chemotherapy as First-Line Treatment for Unresectable, Locally Advanced, Recurrent, or Metastatic ESCC

The purpose of this randomized, multicenter, double-blind, phase 3 trial is to evaluate the efficacy and safety of sintilimab (Tyvyt) versus placebo in combination with chemotherapy (cisplatin plus paclitaxel or cisplatin plus 5-FU) as first-line treatment for patients with unresectable, locally advanced, recurrent, or metastatic ESCC. Patients aged 18 to 75 years with histopathologically confirmed unresectable, locally advanced, recurrent, or metastatic ESCC who have not received systemic treatment for the disease; who have an ECOG performance status of 0 or 1; who are unsuitable for definitive treatment; and whose disease recurrence is >6 months from time of adjuvant or neoadjuvant therapy or definitive chemotherapy/radiochemotherapy may be eligible if other criteria are met. Eligible patients will be randomized to receive either sintilimab 3 mg/kg IV (weight <60 kg) or 200 mg IV (weight ≥60 kg) or placebo every 3 weeks on day 1 plus cisplatin and paclitaxel or cisplatin and 5-FU.

The primary outcome measure is OS in the overall population and in the PD-L1–positive population, from the date of randomization until the date of death from any cause, assessed up to 40 months. Secondary outcome measures include ORR, PFS, disease control rate, and DOR in the overall population and in the PD-L1–positive population, assessed up to 28 months. The study plans to enroll 746 participants throughout the United States and worldwide. For more information, contact James Dean at 1-301-578-2600 ext. 2 or This email address is being protected from spambots. You need JavaScript enabled to view it.. The NLM identifier is NCT03748134.


6. Concurrent Definitive CRT with Pembrolizumab or Placebo in Esophageal Carcinoma

The purpose of this randomized, double-blind, placebo-controlled, phase 3 trial is to assess the efficacy and safety of adding pembrolizumab (Keytruda) or placebo to concurrent definitive CRT as treatment for patients with esophageal carcinoma. Patients aged ≥18 years with histologically or cytologically confirmed ESCC who are ineligible for curative surgery and are not expected to require tumor resection during the study, who have an ECOG performance status of 0 or 1 within 3 days of the first dose of study treatment, who have had previous chemotherapy or radiotherapy for esophageal cancer, and who are deemed suitable for CRT may be eligible if other criteria are met. Eligible patients will be randomized to receive either pembrolizumab 200 mg on day 1 of each 3-week cycle for 8 cycles followed by 400 mg on day 1 of each 6-week cycle for 5 cycles, or placebo, plus either 5-FU plus cisplatin or FOLFOX with radiotherapy.

The primary outcome measures are event-free survival up to 60 months and OS up to 72 months. Secondary outcome measures include the number of participants with an AE and the number of participants discontinuing study treatment due to an AE. The study plans to enroll 700 participants throughout the United States and worldwide. For more information, contact Merck Sharp & Dohme at 1-888-577-8839 or This email address is being protected from spambots. You need JavaScript enabled to view it.. The NLM identifier is NCT04210115.


7. Chemotherapy plus Bemarituzumab or Placebo in FGFR2b-Overexpressed, Unresectable, Locally Advanced, or Metastatic Gastric or GEJ Adenocarcinoma

The purpose of this randomized, multicenter, double-blind, placebo-controlled phase 3 study is to compare the efficacy of bemarituzumab (AMG 552) combined with combined with modified FOLFOX-6 (mFOLFOX-6) versus placebo plus mFOLOFX-6 as treatment for patients with FGFR2b-overexpressed, unresectable, locally advanced, or metastatic gastric or GEJ adenocarcinoma. Patients aged ≥18 years with histologically documented disease not amenable to curative therapy, who have an ECOG performance status of 0 or 1, who have not had other malignancies within the past 2 years, and who have not received previous treatment for metastatic or unresectable disease may be eligible if other criteria are met. Eligible patients will be randomized to receive bemarituzumab IV or placebo IV with mFOLFOX-6 IV.

The primary outcome measure is OS up to approximately 3.5 years. Secondary outcome measures include PFS, ORR, the number of participants having a treatment-emergent AE, OS, DOR, disease control rate, change from baseline score and time to deterioration in EORTC QLQ-C30 score, and the number of participants with antibemarituzumab antibody formation. The study plans to enroll 516 participants throughout the United States and worldwide. For more information, contact the Amgen Call Center at 1-866-572-6436 or This email address is being protected from spambots. You need JavaScript enabled to view it.. The NLM identifier is NCT05052801.

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