Chemotherapy-induced AnemiaPhase 2NCT07891377
HEC53856 Tablets for Chemotherapy-induced Anemia in Non-myeloid Malignancies
A Phase 2 study testing HEC53856 tablet and rHuEPO injection in people with Chemotherapy-induced Anemia and Non-Myeloid Malignancy, run by Sunshine Lake Pharma Co., Ltd. at 1 site in China.
Trial summary
A Phase II clinical trial to evaluate the efficacy and safety of different dosing regimens of HEC53856 tablets compared to rHuEPO injection in participants of the CIA trial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chemotherapy-induced Anemia, Non-Myeloid Malignancy
- What is being tested?
- HEC53856 tablet and rHuEPO injection
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- Dec 2026to May 2029
- Phase
- Phase 2
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years old, weight ≥ 40 kg, gender not limited;
- Diagnosed as non myeloid malignant tumor through histology or cytology;
- Bone marrow suppression chemotherapy related anemia, defined as Hb ≤ 100 g/L during the screening period, and according to the researcher's judgment, there are records showing that the Hb level of the trial participants has decreased by ≥ 10 g/L after the start of previous chemotherapy;
- Plan to receive at least 6 weeks of tumor treatment simultaneously ;
- Eastern Cancer Collaboration Group (ECOG) Physical Fitness Status Score: 0-2 points;
- Expected survival time ≥ 6 months;
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- ferritin ≥ 50 ng/mL and transferrin saturation (TSAT) ≥ 10%;
- Participants in the experiment must have appropriate organ function and meet all of the following laboratory test results before enrollment:
- Liver function: ALT and AST ≤ 3 × ULN; Serum bilirubin ≤ 1.5 × ULN;
- Renal function: According to the 4-variable MDRD equation, the estimated glomerular filtration rate (eGFR) is ≥ 50 mL/min/1.73 m2.
- Non lactating female trial participants; For female trial participants with fertility: During the screening period, the blood pregnancy test must benegative, and from informed consent signature through 3 months following the last study treatment dose have no plan for oocyte retrieval for in-vitro fertilization (IVF) and must agree to take effective contraceptive measures.
- For male trial participants who have not been sterilized: from informed consent signature through 3 months following the last study treatment dose,have no plan to donate sperm and must agree to take effective contraceptive measures.
- The definition and contraception guidelines for "women with fertility" can be found in section 15.3.
- Voluntarily participate in this study and sign a written informed consent form.
Who cannot join
- Participants receiving bone marrow suppressive chemotherapy with an expected outcome of cure;
- Uncontrolled central nervous system metastasis; Or confirm central nervous system metastasis, but have not been stabilized for more than 4 weeks after anti-tumor treatment (definition of stable central nervous system metastasis: no new neurological deficits caused by central nervous system metastasis have been found, no new lesions have been detected by central nervous system imaging examination, and no corticosteroid/steroid treatment is needed); Or malignant neoplasms with primary central nervous system origin or bone-marrow involvement, or malignant tumors of the myeloid system (such as chronic myeloid leukemia, etc.);
- Hematocrit (HCT) ≥ 36%;
- Plan to undergo major surgery during the treatment period;
- traditional Chinese patent medicines and simple preparations that has received anemia treatment within 2 weeks before randomization or RBC infusion or anemia treatment drugs within 4 weeks before randomization, including but not limited to erythropoiesis stimulators (ESAs) and their derivatives, hypoxia inducible factor proline hydroxylase (HIF-PHD) inhibitor, androgen and anabolic hormone drugs;
- Receive live vaccines (including attenuated live vaccines) within the first 4 weeks of randomization;
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- Participants who have participated in any interventional clinical trials and received investigational drugs or medical device interventions within the first 4 weeks of randomization (excluding participants in overall survival follow-up trials who only participated in one study), or plan to use these drugs during their participation in this clinical trial;
- Only accept hormone preparations, biologics, novel immunosuppressive agents (such as PD-1 and PD-L1 immune checkpoint inhibitors), targeted biotherapy, or radiation therapy to treat/control their tumors. Note: If chemotherapy is combined with these drugs or if the treatment received contains antibody conjugated drugs (ADCs), it can be included in the study;
- Currently using or expected to use dapsone during the study treatment period;
- There is known, active, or chronic bleeding present;
- Anemia of clinical significance caused by other etiologies, such as iron deficiency, vitamin B12 or folate deficiency, autoimmune anemia, hemolysis, hemorrhage, sickle cell anemia or thalassemia, etc;
- Persistent inflammation/autoimmune diseases that are clinically significant or uncontrolled (such as rheumatoid arthritis, Crohn's disease, celiac disease, etc.);
- Any of the following cardiovascular risk factors:
- Any history of significant clinical arrhythmia (such as rapid atrial fibrillation, high-grade atrioventricular block, ventricular tachycardia, ventricular fibrillation, or apical torsion ventricular tachycardia);
- Left ventricular ejection fraction (LVEF) is less than 50% during the screening period;
- Individuals who have had any of the following diseases within the first 12 months of randomization: myocardial infarction, coronary artery bypass grafting or peripheral artery bypass grafting surgery, heart failure (New York Heart Association functional class III-IV), etc; Or have unstable angina pectoris within the first 6 months of randomization; Or a history of severe valvular or endocardial disease that may put trial participants at risk of thromboembolism;
- Uncontrollable hypertension (despite receiving antihypertensive medication, systolic blood pressure>160 mmHg, or diastolic blood pressure>100 mmHg), or a history of hypertensive crisis or hypertensive encephalopathy;
- Within the first 6 months of randomization, there has been a history of thrombosis or embolism events, such as cerebrovascular accidents (including transient ischemic attacks, excluding lacunar cerebral infarction), deep vein thrombosis, pulmonary embolism, etc., or receiving therapeutic doses of anticoagulant drugs within 2 weeks before the first medication;
- Prior to randomization, the investigater determined the presence of uncontrollable active systemic infections;
- Suffering from congenital or acquired immune dysfunction (such as HIV infected individuals); Or partcipants with active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection: who are HBsAg positive or HBcAb positive during the screening period need to be tested for HBV DNA, and HBV DNA quantification ≥ 104 cps/mL or ≥ 2000 IU/mL; Participants with positive HCV antibody test results require further HCV RNA testing, and have positive quantitative HCV RNA;
- History of severe liver disease or active liver disease;
- Clinically significant gastrointestinal abnormalities that may affect drug intake, transport, or absorption (such as inability to swallow, chronic diarrhea, intestinal obstruction, etc.), or total gastrectomy;
- Individuals with a history of severe allergic diseases or drug allergies, or known allergies to rHuEPO injection or HEC53856 tablets;
- Individuals with a history of abuse of psychotropic drugs and unable to quit, or those with mental disorders;
- Researchers believe that patients with other serious acute or chronic diseases are not suitable to participate in clinical trials.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Shanghai Chest Hospital
Shanghai, 200030
Lu Shun, MD, 86+021-22200000-3403, shun_lu@hotmail.com
About this study
Official title: A Multicenter, Randomized, Open-label, Positive-controlled Phase 2 Clinical Trial of HEC53856 Tablets Versus Recombinant Human Erythropoietin Injection in the Treatment of Chemotherapy-induced Anemia in Patients With Non-myeloid Malignancies
A Phase II clinical trial to evaluate the efficacy and safety of different dosing regimens of HEC53856 tablets compared to rHuEPO injection in participants of the CIA trial.
Read the detailed description
This study is a multicenter, randomized, open-label, phase II clinical trial with a positive control, aimed at evaluating the efficacy and safety of different dosing regimens of HEC53856 tablets compared to Recombinant Human Erythropoietin (rHuEPO) injection in participants of the Chemotherapy-induced Anemia (CIA) trial.
- Being tested
- HEC53856 tablet, rHuEPO injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HEC53856 tabletDrug
The experimental cohort is divided into four groups: 20 mg once a day (QD) group, 40 mg QD group, 60 mg QD group, and 100 mg three times a week [TIW] group. Participants in the experimental cohort will take HEC53856 tablets orally either in the fasted state or after meals.
rHuEPO injectionDrug
rHuEPO Injection 36000 IU will be subcutaneously administered once weekly [QW].
| Study group | Role | What they receive |
|---|---|---|
| HEC53856 Tablets | Experimental | Participants in the experimental cohort will take HEC53856 tablets orally, each treatment cycle is 3 weeks. The treatment will continue until the termination criteria are met, and the dosage can be adjusted according to the protocol standards. Receives: Drug: HEC53856 tablet |
| rHuEPO injection | Active comparator | Participants in the positive control group are administered rHuEPO injection. Each treatment cycle is 3 weeks and treatment will continues until the termination criteria are met. The dosage can be adjusted according to the instructions or plan. Receives: Drug: rHuEPO injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
The compliance rate of hemoglobin (Hb) in trial participants at week 7
The proportion of participants who met the hemoglobin (Hb) standard (defined as 100<Hb ≤ 120 g/L) in the 7th week
Measured: Week 7
Secondary outcomes (9)
Hemoglobin (Hb) Response Rate
The proportion of participants achieving Hb targets at each preset visit point during the trial period (including the study treatment end visit; excluding the 7th week)
Measured: Up to around 15 weeks
The average Hb compliance rate of participants at each preset visit point during the trial period
During the trial, the average Hb target achievement rate at the preset study visits was calculated.
Measured: Up to around 15 weeks
Mean change of Hb
Mean change from baseline in hemoglobin level assessed from Week 7 through the end-of-treatment visit.
Measured: From Week 7 to around week 15
The proportion of trial participants with Hb increased by ≥10 / 15 / 20 g/L from baseline
Proportion of participants achieving hemoglobin increase of at least 10 g/L, 15 g/L, or 20 g/L relative to baseline.
Measured: Up to around 15 weeks
The time when Hb increased by ≥10 /15/20 g/L compared to baseline
Time from randomization to first occurrence of hemoglobin increase of at least 10 g/L, 15 g/L, or 20 g/L relative to baseline.
Measured: Up to around 15 weeks
The proportion of trial participants whose chemotherapy dosage is reduced or suspended due to anemia.
Study the proportion of trial participants whose chemotherapy dosage is reduced or suspended due to anemia during treatment.
Measured: Up to around 15 weeks
Proportion of participants with non-response
Proportion of participants meeting non-response criteria defined as requirement for red blood cell transfusion or hemoglobin less than 60 g/L, assessed from Week 5 to end of treatment.
Measured: From Week 5 to around week 15
Number and volume of red blood cell transfusions
Number of red blood cell transfusions and transfusion volume from baseline to the end of treatment.
Measured: From baseline to around week 15
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
Adverse events in this study will be evaluated according to CTCAE V6.0
Measured: Up to around 15 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2026
- Study startDec 2026 (estimated)
- Primary completionFeb 2028 (estimated)
- Study completionMay 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy-induced AnemiaStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunshine Lake Pharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07891377
- Sponsor's protocol ID
- HEC53856-CIA-202
- Status last verified
- Sep 2026
- First submitted
- 14 Oct 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No