Esophageal Squamous Cell CarcinomaPhase 1NCT05927844
XH-30002 Capsule Combined With Afatinib Tablets for the Treatment of Squamous Cell Carcinoma
A Phase 1 study testing XH-30002 capsule and Afatiinb tablet in people with Esophageal Squamous Cell Carcinoma, run by Fujian Cancer Hospital.
Trial summary
This study is an exploratory clinical trial and does not involve statistical assumptions or sample size estimation. the mainly purpose for the study is to evaluate the safety of XH-30002 capsule combined with afatinib tablets in the treatment of locally advanced or metastatic esophageal squamous cell carcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Squamous Cell Carcinoma
- What is being tested?
- XH-30002 capsule and Afatiinb tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Jun 2023to Jun 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Voluntarily participate in the study, agree to complete the corresponding visit and inspection according to the research plan, and sign the informed consent form (ICF);
- Age ≥18 years old (as of the date of signing the ICF);
- Esophageal squamous cell carcinoma confirmed by histology or cytology;
- Patients with disease progression or intolerance after receiving at least first-line systemic treatment or refusing to accept standard treatment for various reasons;
- The physical status score of the Eastern United States Oncology Consortium (ECOG) was 0-2;
- Presence of at least one evaluable lesion according to RECIST 1.1 evaluation criteria;
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- Within 7 days before the first dose, the function of major organs and bone marrow meets the following criteria (in cases where blood transfusion or hematopoietic stimulation is not corrected within 14 days before the test) :
- Neutrophil count ≥1.5×109/L;
- Platelet count ≥100×109/L;
- Hemoglobin ≥90g/L;
- Liver function: For subjects with total bilirubin (TBIL) ≤1.5× upper reference value (ULN) or TBIL>1.5×ULN, direct bilirubin ≤1.0×ULN; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN (liver metastasis subjects ≤5×ULN); Albumin ≥3.0g/dL;
- Renal function: serum creatinine ≤1.5×ULN or creatinine clearance ≥50mL/min (calculated by Cockcroft-Gault formula);
- Coagulation function: International standardized ratio (INR) ≤1.5, and activated partial thromboplastin time (APTT) ≤1.5×ULN;
- Expected survival time ≥3 months;
- Women of reproductive age must undergo a negative blood pregnancy test within 7 days prior to enrollment and agree to use a reliable and effective method of contraception during the study treatment period and for 6 months after the last study treatment; For male subjects whose partner is a woman of reproductive age, consent must be given to use a reliable and effective method of contraception during the study treatment period and for 6 months after the last study treatment (whichever is the longest).
Who cannot join
- Past or current use of afatinib maleate tablets or anti-tumor drugs targeting CDK4/6;
- the presence of other active malignancies within 3 years prior to the first dose, except for locally curable tumors that have already received radical treatment (e.g., resected basal or squamous cell skin cancer, superficial bladder cancer, breast carcinoma in situ, early thyroid cancer, etc.);
- Within 7 days before the first dose, there is uncontrollable serosal effusion requiring frequent drainage or medical intervention (such as pleural effusion, abdominal effusion, pericardial effusion, etc.);
- Patients with central nervous system metastases (except asymptomatic brain metastases);
- The toxicity level of previous anti-tumor therapy has not been restored to the General Adverse Event Term Standard 5.0 (CTCAE5.0) ≤ grade 1 (alopecia, peripheral neurotoxicity, simple laboratory tests and other toxicity that researchers judge no safety risk need to be mitigated to ≤ grade 2);
- Those who have used potent inhibitors or inducers of CYP3A4 or CYP2C8 within 14 days before the first dose;
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- A history of hypersensitivity to any investigational drug ingredient or any known excipient
- Patients with uncontrolled or significant cardiovascular and cerebrovascular diseases, including but not limited to:
- New York Heart Association (NYHA) Class II or higher congestive heart failure, unstable angina pectoris, myocardial infarction, or arrhythmia causing hemodynamic instability in the six months prior to screening;
- primary cardiomyopathy (e.g., dilated cardiomyopathy, hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, restricted cardiomyopathy, undefined cardiomyopathy);
- a history of clinically significant QT interval prolongation, or a screening period QTcF (calculated using Fridericia's formula) > 450 ms; Left ventricular ejection fraction (LVEF) ≤50%;
- Occurrence of arterial/venous thrombosis events, such as cerebrovascular accidents (including temporary ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism, etc. within 6 months before screening;
- Uncontrolled hypertension after optimal treatment (systolic blood pressure > 160mmHg or diastolic blood pressure > 100mmHg);
- Esophagotracheal fistula, esophagomediastinal fistula, or tumor invasion risk of surrounding large blood vessels were diagnosed by imaging examination;
- Gastrointestinal obstruction and active inflammatory bowel disease within 28 days prior to initial administration; The presence of chronic gastrointestinal dysfunction with diarrhea as the main symptom or other gastrointestinal disorders determined by investigators to be clinically significant, such as Crohn's disease, ulcerative colitis, malabsorption, or grade 1 diarrhea;
- Patients with active hepatitis B [hepatitis B surface antigen (HBsAg) or HBcAb test positive and HBV-DNA≥ upper limit of normal] or hepatitis C [hepatitis C antibody (Anti-HCV) test positive and HCV-RNA≥ upper limit of normal] during the screening period;
- Known history of human immunodeficiency virus (HIV) infection;
- Serious chronic or active infected persons (including tuberculous infections) who require systemic antibacterial, antifungal, or antiviral treatment within 14 days prior to initial administration;
- Received traditional Chinese medicine or radiation therapy with anti-tumor indications within 14 days before the first dose; Those who have received anti-tumor therapy such as targeted therapy, immunotherapy or other investigational drugs within 28 days or 5 half-lives prior to the first dose, whichever is shorter;
- Those who had undergone major organ surgery within 28 days prior to initial dosing or planned to undergo elective surgery during the trial period (excluding needle biopsy);
- Those who were vaccinated 28 days before the first dose or planned to be vaccinated during the trial;
- Pregnant or lactating women;
- Participating in other interventional clinical studies during the screening period (except non-interventional clinical studies or follow-up period of interventional studies);
- Known history of mental or neurological disorders that may affect compliance with the test; People with drug or alcohol dependence; There are other investigators evaluating subjects who are not suitable for participation in this study.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: An Open, Single-arm, Multicenter Phase Ib Clinical Study of XH-30002 Capsule Combined With Afatinib Tablets for the Treatment of Locally Advanced or Metastatic Esophageal Squamous Cell Carcinoma
This study is an exploratory clinical trial and does not involve statistical assumptions or sample size estimation. the mainly purpose for the study is to evaluate the safety of XH-30002 capsule combined with afatinib tablets in the treatment of locally advanced or metastatic esophageal squamous cell carcinoma.
Read the detailed description
This is an open, single-arm, multicenter, investigator-initiated Phase Ib clinical study to evaluate the efficacy and safety of XH-30002 capsule in combination with afatinib maleate tablets in patients with locally advanced or metastatic esophageal squamous cell carcinoma. The primary endpoint of the study was the safety of XH-30002 capsule combined with afatinib maleate tablets.
- Conditions
- Esophageal Squamous Cell Carcinoma
- Being tested
- XH-30002 capsule, Afatiinb tablet
- Medical subject headings
- Esophageal Squamous Cell Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XH-30002 capsuleDrug
receive the study drug until the investigator assessed no longer benefit, toxic intolerance, withdrawal of consent, loss of follow-up, or death, whichever occurred first
Afatiinb tabletDrug
receive the study drug until the investigator assessed no longer benefit, toxic intolerance, withdrawal of consent, loss of follow-up, or death, whichever occurred first
| Study group | Role | What they receive |
|---|---|---|
| Treatment ARM1 | Experimental | Drugs1：XH30002 Capsual 300mg，Qd，28d; Drug2：Afatiinb tablets 30mg，Qd，28d Receives: Drug: XH-30002 capsule; Drug: Afatiinb tablet |
| Treatment ARM2 | Experimental | Drugs1：XH30002 Capsual 400mg，Qd，28d; Drug2：Afatiinb tablets 30mg，Qd，28d Receives: Drug: XH-30002 capsule; Drug: Afatiinb tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Related Adverse Events and SAE
The Treatment-Related Adverse Events and SAE will be assessed by CTCAE5.0.
Measured: through study completion, an average of 6 months
severity of TEAE and SAE
The Treatment-Related Adverse Events and SAE will be assessed by CTCAE5.0.
Measured: through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study startJun 2023 (estimated)
- Primary completionJun 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Fujian Cancer HospitalThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- open, single-arm
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Gen Lin, Ph.D, Principal investigator, Fujian Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05927844
- Sponsor's protocol ID
- SCOG007
- Status last verified
- Jun 2023
- First submitted
- 14 Jun 2023
- Last updated
- 3 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Will decided after the study initiated.
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Single-arm, Multicenter Phase Ib Clinical Study of XH-30002 Capsule Combined With Afatinib Tablets for the Treatment of Locally Advanced or Metastatic Esophageal Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT05927844
- Acronym / sponsor ID
- SCOG007
- Conditions
- Esophageal Squamous Cell Carcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Fujian Cancer HospitalOther government
- Study start
- Jun 2023 (estimated)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 3 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is an exploratory clinical trial and does not involve statistical assumptions or sample size estimation. the mainly purpose for the study is to evaluate the safety of XH-30002 capsule combined with afatinib tablets in the treatment of locally advanced or metastatic esophageal squamous cell carcinoma.
Detailed description
This is an open, single-arm, multicenter, investigator-initiated Phase Ib clinical study to evaluate the efficacy and safety of XH-30002 capsule in combination with afatinib maleate tablets in patients with locally advanced or metastatic esophageal squamous cell carcinoma. The primary endpoint of the study was the safety of XH-30002 capsule combined with afatinib maleate tablets.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- open, single-arm
| Arm | Type | Receives |
|---|---|---|
| Treatment ARM1 | Experimental | Drug: XH-30002 capsule, Drug: Afatiinb tabletDrugs1：XH30002 Capsual 300mg，Qd，28d; Drug2：Afatiinb tablets 30mg，Qd，28d |
| Treatment ARM2 | Experimental | Drug: XH-30002 capsule, Drug: Afatiinb tabletDrugs1：XH30002 Capsual 400mg，Qd，28d; Drug2：Afatiinb tablets 30mg，Qd，28d |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Voluntarily participate in the study, agree to complete the corresponding visit and inspection according to the research plan, and sign the informed consent form (ICF);
- Age ≥18 years old (as of the date of signing the ICF);
- Esophageal squamous cell carcinoma confirmed by histology or cytology;
- Patients with disease progression or intolerance after receiving at least first-line systemic treatment or refusing to accept standard treatment for various reasons;
- The physical status score of the Eastern United States Oncology Consortium (ECOG) was 0-2;
Key exclusion criteria (24 listed)
- Past or current use of afatinib maleate tablets or anti-tumor drugs targeting CDK4/6;
- the presence of other active malignancies within 3 years prior to the first dose, except for locally curable tumors that have already received radical treatment (e.g., resected basal or squamous cell skin cancer, superficial bladder cancer, breast carcinoma in situ, early thyroid cancer, etc.);
- Within 7 days before the first dose, there is uncontrollable serosal effusion requiring frequent drainage or medical intervention (such as pleural effusion, abdominal effusion, pericardial effusion, etc.);
- Patients with central nervous system metastases (except asymptomatic brain metastases);
- The toxicity level of previous anti-tumor therapy has not been restored to the General Adverse Event Term Standard 5.0 (CTCAE5.0) ≤ grade 1 (alopecia, peripheral neurotoxicity, simple laboratory tests and other toxicity that researchers judge no safety risk need to be mitigated to ≤ grade 2);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XH-30002 capsulereceive the study drug until the investigator assessed no longer benefit, toxic intolerance, withdrawal of consent, loss of follow-up, or death, whichever occurred first | Drug | Treatment ARM1, Treatment ARM2 |
| Afatiinb tabletreceive the study drug until the investigator assessed no longer benefit, toxic intolerance, withdrawal of consent, loss of follow-up, or death, whichever occurred first | Drug | Treatment ARM1, Treatment ARM2 |
Primary outcome
Incidence of Treatment-Related Adverse Events and SAE
Time frame: through study completion, an average of 6 months
The Treatment-Related Adverse Events and SAE will be assessed by CTCAE5.0.
severity of TEAE and SAE
Time frame: through study completion, an average of 6 months
The Treatment-Related Adverse Events and SAE will be assessed by CTCAE5.0.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2023.
- Individual participant dataSharing planned: No. Will decided after the study initiated.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gen Lin, Ph.D principal investigator
Fujian Cancer Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing XH-30002 capsule and Afatiinb tablet in people with Esophageal Squamous Cell Carcinoma, run by Fujian Cancer Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gen Lin, Ph.D (+86-13313786157, fjzllg133@fjzlhospital.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Related Adverse Events and SAE (time frame: through study completion, an average of 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2023.