AN0025 and Chemoradiotherapy Combination in Esophageal Cancer
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT05191667 |
Recruitment Status :
Not yet recruiting
First Posted : January 13, 2022
Last Update Posted : January 13, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Esophageal Cancer | Drug: AN0025 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 42 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | An Open-Label Multicenter Phase Ib Study of AN0025 in Combination With Chemoradiotherapy in Patients With Locally Advanced/Locally Recurrent Esophageal Cancer |
Estimated Study Start Date : | January 2022 |
Estimated Primary Completion Date : | December 2024 |
Estimated Study Completion Date : | December 2025 |

Arm | Intervention/treatment |
---|---|
Experimental: Ph1: Patients that can be surgically resected with potential
Patients will receive AN0025 orally once daily (QD) and chemoradiotherapy as neoadjuvant treatment followed by a surgery
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Drug: AN0025
250 mg or 500 mg Q.D., oral administration |
Experimental: Ph1: Patients can be surgically resected with potential but are evaluated as inoperable later
Patients will receive AN0025 orally once daily (QD) and chemoradiotherapy as neoadjuvant treatment followed by a radical chemoradiotherapy.
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Drug: AN0025
250 mg or 500 mg Q.D., oral administration |
Experimental: Ph1: Patients with unresectable locally advanced/locally recurrent esophageal cancer
Patients will receive AN0025 orally once daily (QD) and chemoradiotherapy.
|
Drug: AN0025
250 mg or 500 mg Q.D., oral administration |
- Number of participants with Dose Limiting Toxicities (DLTs) [ Time Frame: 4 weeks ]
- The rate of histopathologically confirmed complete response (pCR) rate [ Time Frame: 2 years ]
- R0 resection rate [ Time Frame: 2 years ]
- Disease-free survival (DFS) [ Time Frame: 2 years ]
- Progression-free survival (PFS) [ Time Frame: 2 years ]
- Overall survival (OS) [ Time Frame: 2 years ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Diagnosed with histologically- and/or cytologically-confirmed locally advanced/locally recurrent squamous cell carcinoma or adenocarcinoma of the esophagus or of the esophagogastric junction (EGJ).
- Have measurable disease per RECIST 1.1 as assessed by the local site investigator and/or radiologist.
- Male or female, age≥18 years at the time of informed consent.
- Have provided signed informed consent for the trial and are willing to comply with all aspects of the protocol
Exclusion Criteria:
- With a history of another primary malignancy within the past 2 years, with the exception of basal or squamous cell skin cancer, or carcinoma in situ of the cervix or breast that has undergone potentially curative therapy.
- Participants with known Hepatitis B or C infections, or known to be positive for Hepatitis B antigen (HBsAg)/ Hepatitis B virus (HBV) DNA or Hepatitis C antibody (HepC Ab)/ Hepatitis C virus (HCV) RNA. Active Hepatitis B is defined by a known positive HepB Ab result and known quantitative HBV DNA results greater than the lower limits of detection of the assay. Active Hepatitis C is defined by a known positive HepC Ab result and known quantitative HCV RNA results greater than the lower limits of detection of the assay.
- Participants with known human immunodeficiency virus (HIV) infection (positive for HIV-1/2 antibody) or syphilis infection (positive for syphilis spiral antibody).
- Major surgery or severe trauma within 4 weeks before the first dose of study drug. Note: If participant received major surgery, they must have recovered adequately from surgery and the toxicity and/or complications requiring the intervention prior to starting study treatment.
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Have received prior systemic anti-cancer therapy including chemotherapy, target therapy, immunotherapy, anti-cancer traditional Chinese medicine, and other investigational oncology agents within 4 weeks or 5 half-lives, whichever is shorter. Participants who have entered the follow-up phase of an investigational study may participate as long as it has been at least 4 weeks (or 5 half-lives, whichever is shorter) after the last dose of the previous investigational agent.
Note: Participants must have recovered from all AEs due to previous therapies to ≤ Grade 1 or returned to baseline. Participants with ≤ Grade 2 neuropathy or alopecia (per CTCAE v5.0) may be eligible.
- Are currently participating in a study of an investigational device within 4 prior to the first dose of study treatment.
- Have uncontrolled tumor-related pain.
- Have a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study.
- Have a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator.

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): NCT05191667
China | |
Chinese PLA General Hospital | |
Beijing, China |
Responsible Party: | Adlai Nortye Biopharma Co., Ltd. |
ClinicalTrials.gov Identifier: | NCT05191667 |
Other Study ID Numbers: |
AN0025S0104 |
First Posted: | January 13, 2022 Key Record Dates |
Last Update Posted: | January 13, 2022 |
Last Verified: | December 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
Esophageal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms |
Head and Neck Neoplasms Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases |