Advanced Oesophageal Squamous Cell CarcinomaPhase 3NCT06656091
A Study of Simmitinib Versus Chemotherapy for Participants With Advanced Oesophageal Squamous Cell Carcinoma
A Phase 3 study testing simmitinib and investigator's choice of chemotherapy,include docetaxel or irinotecan. in people with Advanced Oesophageal Squamous Cell Carcinoma, run by Shanghai Runshi Pharmaceutical Technology Co., Ltd.
Trial summary
To evaluate the overall survival of simmitinib versus investigator's choice of chemotherapy for Participants with advanced or metastatic oesophageal squamous cell carcinoma who have disease progression after first-line standard therapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Oesophageal Squamous Cell Carcinoma
- What is being tested?
- simmitinib and investigator's choice of chemotherapy,include docetaxel or irinotecan.
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- No sites listed yet
- Study dates
- 31 Oct 2024to 30 Jan 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Have fully understood and voluntarily sign the ICF for this study; 2. Age of 18-75 years (inclusive), male or female； 3. Histologically or cytologically confirmed esophageal squamous cell carcinoma with locally advanced unresectable, local recurrence or with distant metastasis； 4. Second-line patients with disease progression after only first-line standard therapy（Standard treatment: Chemotherapy with platinum, paclitaxel, or fluorouracil combined with immunosuppressive regimen. Progression during maintenance therapy will be allowed.Concurrent chemoradiotherapy with recurrence or metastasis after surgery is considered as first-line treatment. Progression during Concurrent chemoradiotherapy/ adjuvant/neoadjuvant therapy or within 6 months of the last dose is considered a first-line standard treatment failure）; 5. At least one evaluable lesion according to RECIST 1.1; 6. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0-1; 7. Expected survival is more than 3 months； 8. Have recovered from any prior adverse effects of chemotherapy, surgery, radiation, or other antitumor therapy to CTCAE V5.0 criteria ≤ Grade 1 or baseline (except for toxicity such as hair loss that the investigator determines is not a safety risk)； 9. Adequate organ function, defined as:
- Absolute Neutrophil count (ANC) ≥ 1.5 × 10^9/L;
- Platelet count (PLT) ≥ 100× 10^9/L;
- Hemoglobin (Hb) ≥ 90 g/L;
- Serum creatinine ≤ 1.5 × ULN and Creatinine clearance (CCr)≥60mL/min(According to the Cockcroft-Gault formula);
- Serum total bilirubin (TBIL) ≤ 1.5 × ULN;
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × upper limit of normal (ULN) (≤ 5.0 × ULN for patients with liver metastases);
- Prothrombin time (PT)、activated partial thromboplastin time (APTT)、international normalized ratio(INR)≤1.5 × ULN(No previous anticoagulant therapy) 10. Male and female patients of childbearing age must agree to take effective contraceptive measures during treatment and within 6 months after the last dose of treatment. Female participants must have a negative serum or urine pregnancy test result within 7 days prior to randomization and must be non-lactating.
Who cannot join
- 1. Patients who have previously received any anti-tumor therapy within 4 weeks prior to randomization; 2. Patients who have previously received major surgical treatment、open biopsy、other clinical trial drug treatment or any live attenuated vaccine within 4 weeks prior to randomization, or are expected to received any live attenuated vaccine during the study.
- 3. Patients who have previous treatment with anti-angiogenic drugs (such as anlotinib, apatinib, Fruquintinib, Surufatinib, Bevacizumab, etc.) 4. LVEF <50%； 5. BMI≤18.5 kg/m^2； 6. Symptomatic central nervous system (CNS) metastases or meningeal metastases 7. Patients with other types of malignant tumors within 5 years prior to the screening, except for radically resected, non-recurrent skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, cervical cancer in situ, or other carcinoma in situ； 8. Patients with bleeding tendency; active bleeding or a history of heavy bleeding within the past 6 months； 9. Urine protein ≥ ++ and 24 h urine protein > 1.0 g at screening period； 10. Presence of any severe and/or uncontrolled disease before starting treatment； 11. Patients with Liver cirrhosis or active hepatitis； 12. Patients with abdominal fistula, tracheoesophageal fistula, gastrointestinal perforation, or abdominal abscess within 6 months before randomization； 13. Patient previously had or currently has a mental disorder or suffers from epilepsy and requires treatment； 14. Patients had prior retinal pigment epithelial detachment or have evidence of ongoing retinal pigment epithelial detachment； 15. Any active infection requiring antibiotics or hormones systemic treatment by intravenous infusion within 14 days prior to randomization; 16. Patients had prior interstitial lung disease,or have evidence of active non-infectious pneumonia treated with corticosteroids； 17. Inability to swallow drugs orally, or presence of clinically significant gastrointestinal disorders.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Simmitinib Versus Investigator's Choice of Chemotherapy for Participants With Advanced or Metastatic Oesophageal Squamous Cell Carcinoma : a Randomised, Open-label, Multicentre, Phase 3 Study
To evaluate the overall survival of simmitinib versus investigator's choice of chemotherapy for Participants with advanced or metastatic oesophageal squamous cell carcinoma who have disease progression after first-line standard therapy.
Read the detailed description
This is a randomised, open-label, multicentre, phase 3 study. Participants with advanced or metastatic oesophageal squamous cell carcinoma who have disease progression after first-line standard therapy will be randomly assigned to the experimental group or control group in a 1:1 ratio. The experimental group received treatment with Simmitinib, while the control group received investigator's choice of chemotherapy, include docetaxel or irinotecan.
- Being tested
- simmitinib, investigator's choice of chemotherapy,include docetaxel or irinotecan.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
simmitinibDrug
simmitinib 6mg,QD ,3 weeks on 1 week off
investigator's choice of chemotherapy,include docetaxel or irinotecan.Drug
docetaxel injection 75mg/m^2,d1,every 3 weeks or ilinotecan injection 180mg/m^2,d1,every 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| simmitinib | Experimental | simmitinib 6mg,QD ,3 weeks on 1 week off Receives: Drug: simmitinib |
| investigator's choice of chemotherapy | Active comparator | docetaxel injection 75mg/m^2,d1,every 3 weeks；or ilinotecan injection 180mg/m^2,d1,every 2 weeks Receives: Drug: investigator's choice of chemotherapy,include docetaxel or irinotecan. |
What is being measured
The primary outcome is the main question the study is designed to answer.
OS
Measured: up to approximately 3 years
Secondary outcomes (7)
ORR
Objective Response Rate (ORR) evaluated by investigators based on RECIST 1.1
Measured: up to approximately 3 years
PFS
Progression-free Survival
Measured: up to approximately 3 years
DCR
Disease Control Rate
Measured: up to approximately 3 years
DOR
Duration of Objective Response
Measured: up to approximately 3 years
AE
Incidence rate of Adverse Event
Measured: From first dose to 28 days post the last dose
FGF19 protein expression, FGF gene amplification status
IHC detection of FGF19 protein expression in tumor tissues FISH detection of FGF19 gene amplification status in tumor tissues NGS detection of FGF-FGFR pathway related gene status, including gene amplification, mutation, or fusion
Measured: baseline
PK
Plasma Concentration of simmitinib
Measured: Cycle 1 Day 1 to Cycle 2 Day 15 (each cycle is 28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2024
- Study start31 Oct 2024 (estimated)
- Primary completion30 Jan 2027 (estimated)
- Study completion30 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Oesophageal Squamous Cell CarcinomaStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- simmitinib 6mg,QD ,3 weeks on 1 week off Control Group：investigator's choice of chemotherapy,include docetaxel or irinotecan. docetaxel injection 75mg/m\^2,d1,every 3 weeks； ilinotecan injection 180mg/m\^2,d1,every 2 weeks
- Masking
- None (open label)
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Runshi Pharmaceutical Technology Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ruihua Xu, Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06656091
- Sponsor's protocol ID
- HA1818-008
- Status last verified
- Oct 2024
- First submitted
- 14 Oct 2024
- Last updated
- 24 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simmitinib Versus Investigator's Choice of Chemotherapy for Participants With Advanced or Metastatic Oesophageal Squamous Cell Carcinoma : a Randomised, Open-label, Multicentre, Phase 3 Study
- ClinicalTrials.gov ID
- NCT06656091
- Acronym / sponsor ID
- HA1818-008
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Shanghai Runshi Pharmaceutical Technology Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 31 Oct 2024 (estimated)
- Primary completion
- 30 Jan 2027 (estimated)
- Study completion
- 30 Jan 2027 (estimated)
- First posted
- 24 Oct 2024 (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.
To evaluate the overall survival of simmitinib versus investigator's choice of chemotherapy for Participants with advanced or metastatic oesophageal squamous cell carcinoma who have disease progression after first-line standard therapy.
Detailed description
This is a randomised, open-label, multicentre, phase 3 study. Participants with advanced or metastatic oesophageal squamous cell carcinoma who have disease progression after first-line standard therapy will be randomly assigned to the experimental group or control group in a 1:1 ratio. The experimental group received treatment with Simmitinib, while the control group received investigator's choice of chemotherapy, include docetaxel or irinotecan.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- simmitinib 6mg,QD ,3 weeks on 1 week off Control Group：investigator's choice of chemotherapy,include docetaxel or irinotecan. docetaxel injection 75mg/m^2,d1,every 3 weeks； ilinotecan injection 180mg/m^2,d1,every 2 weeks
| Arm | Type | Receives |
|---|---|---|
| simmitinib | Experimental | Drug: simmitinibsimmitinib 6mg,QD ,3 weeks on 1 week off |
| investigator's choice of chemotherapy | Active comparator | Drug: investigator's choice of chemotherapy,include docetaxel or irinotecan.docetaxel injection 75mg/m^2,d1,every 3 weeks；or ilinotecan injection 180mg/m^2,d1,every 2 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 1. Have fully understood and voluntarily sign the ICF for this study; 2. Age of 18-75 years (inclusive), male or female； 3. Histologically or cytologically confirmed esophageal squamous cell carcinoma with locally advanced unresectable, local recurrence or with distant metastasis； 4. Second-line patients with disease progression after only first-line standard therapy（Standard treatment: Chemotherapy with platinum, paclitaxel, or fluorouracil combined with immunosuppressive regimen. Progression during maintenance therapy will be allowed.Concurrent chemoradiotherapy with recurrence or metastasis after surgery is considered as first-line treatment. Progression during Concurrent chemoradiotherapy/ adjuvant/neoadjuvant therapy or within 6 months of the last dose is considered a first-line standard treatment failure）; 5. At least one evaluable lesion according to RECIST 1.1; 6. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0-1; 7. Expected survival is more than 3 months； 8. Have recovered from any prior adverse effects of chemotherapy, surgery, radiation, or other antitumor therapy to CTCAE V5.0 criteria ≤ Grade 1 or baseline (except for toxicity such as hair loss that the investigator determines is not a safety risk)； 9. Adequate organ function, defined as:
Key exclusion criteria (2 listed)
- 1. Patients who have previously received any anti-tumor therapy within 4 weeks prior to randomization; 2. Patients who have previously received major surgical treatment、open biopsy、other clinical trial drug treatment or any live attenuated vaccine within 4 weeks prior to randomization, or are expected to received any live attenuated vaccine during the study.
- 3. Patients who have previous treatment with anti-angiogenic drugs (such as anlotinib, apatinib, Fruquintinib, Surufatinib, Bevacizumab, etc.) 4. LVEF <50%； 5. BMI≤18.5 kg/m^2； 6. Symptomatic central nervous system (CNS) metastases or meningeal metastases 7. Patients with other types of malignant tumors within 5 years prior to the screening, except for radically resected, non-recurrent skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, cervical cancer in situ, or other carcinoma in situ； 8. Patients with bleeding tendency; active bleeding or a history of heavy bleeding within the past 6 months； 9. Urine protein ≥ ++ and 24 h urine protein > 1.0 g at screening period； 10. Presence of any severe and/or uncontrolled disease before starting treatment； 11. Patients with Liver cirrhosis or active hepatitis； 12. Patients with abdominal fistula, tracheoesophageal fistula, gastrointestinal perforation, or abdominal abscess within 6 months before randomization； 13. Patient previously had or currently has a mental disorder or suffers from epilepsy and requires treatment； 14. Patients had prior retinal pigment epithelial detachment or have evidence of ongoing retinal pigment epithelial detachment； 15. Any active infection requiring antibiotics or hormones systemic treatment by intravenous infusion within 14 days prior to randomization; 16. Patients had prior interstitial lung disease,or have evidence of active non-infectious pneumonia treated with corticosteroids； 17. Inability to swallow drugs orally, or presence of clinically significant gastrointestinal disorders.
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 |
|---|---|---|
| simmitinibsimmitinib 6mg,QD ,3 weeks on 1 week off | Drug | simmitinib |
| investigator's choice of chemotherapy,include docetaxel or irinotecan.docetaxel injection 75mg/m^2,d1,every 3 weeks or ilinotecan injection 180mg/m^2,d1,every 2 weeks | Drug | investigator's choice of chemotherapy |
Primary outcome
OS
Time frame: up to approximately 3 years
7 secondary outcomes
ORR
Time frame: up to approximately 3 years
PFS
Time frame: up to approximately 3 years
DCR
Time frame: up to approximately 3 years
DOR
Time frame: up to approximately 3 years
AE
Time frame: From first dose to 28 days post the last dose
FGF19 protein expression, FGF gene amplification status
Time frame: baseline
PK
Time frame: Cycle 1 Day 1 to Cycle 2 Day 15 (each cycle is 28 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2024.
- Individual participant dataSharing planned: No
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.
Ruihua Xu principal investigator
Sun Yat-sen University
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing simmitinib and investigator's choice of chemotherapy,include docetaxel or irinotecan. in people with Advanced Oesophageal Squamous Cell Carcinoma, run by Shanghai Runshi Pharmaceutical Technology Co., Ltd.
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 8 inclusion and 2 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: opening soon, as of the sponsor's last update on 24 Oct 2024. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials Information Group officer (031169085587, ctr-contact@cspc.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
OS (time frame: up to approximately 3 years). 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 24 Oct 2024; AzTrials last refreshed its copy on 7 Nov 2026.