Esophageal Squamous Cell CarcinomaPhase 2NCT06487702
A Phase lb/lI Clinical Study in Advanced or Metastatic Esophageal Squamous Cell Carcinoma
A Phase 2 study testing fruquintinib++Candonilimab+ Tegafur，Gimeracil and Oteracil Potassium in people with Esophageal Squamous Cell Carcinoma, run by Rui-hua Xu, MD, PhD at 1 site in China.
Trial summary
This is a prospective, single-arm, open-label，multi-center, phase Ib/II study, aiming to evaluate the efficacy and safety of Fruquintinib combined With Cadonilimab (AK104) and Tegafur，Gimeracil and Oteracil Potassium in patients with locally advanced or metastatic esophageal squamous cell carcinoma after the failure… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Esophageal Squamous Cell Carcinoma
- What is being tested?
- fruquintinib++Candonilimab+ Tegafur，Gimeracil and Oteracil Potassium
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 10 Jul 2024to 10 Jun 2027
- Phase
- Phase 2
- 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
- age:18-75 years old, Male or female patients
- Histologically or cytologically confirmed esophageal squamous cell carcinoma (including the gastroesophageal junction), (Adenosquamous carcinoma with squamous cell carcinoma components-based is allowed to be included)
- Irretrievably resected, local advanced, relapsed or metastatic esophageal squamous cell carcinoma
- Previously received platinum-based systemic anti-tumor first-line therapy; Or received Neoadjuvant, adjuvant therapy, or radical chemoradiotherapy for ESCC, but disease recurrence or progression within 6 months after completion of treatment; no restrictions on prior immunotherapy treatment choice.
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 to 1
- At least one measurable lesion (RECIST1.1)
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- Life expectancy of more than 3 months;
- Women of childbearing age were required to have had a negative pregnancy test (serum or urine) within 14 days before enrollment and to voluntarily use an appropriate method of contraception during the observation period and for 8 weeks after the last dose of the study drug.For men, either surgical sterilization or consent to use an appropriate method of contraception during the observation period and for 8 weeks after the last dose of the study drug was given
- Have fully understood and voluntarily sign the ICF for this study;
- Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure;
- Adequate hepatic, renal, heart, and hematologic functions
Who cannot join
- Have had other malignancies within the past 5 years, except for curatively treated radical skin basal cell or squamous cell carcinoma, Or cervical carcinoma in situ;
- Have received major surgical procedures (such as craniotomy, thoracotomy, or laparotomy) within 4 weeks before enrollment or are excepted to uddergo major surgery during the study treatment; received laparoscopic exploration within 2 weeks before enrollment; received central venous catheterization within 7 days prior to enrollment
- Have received chemotherapy, targeted therapy, traditional Chinese herbal medicine with anti-tumor indications or immunomodulatory drugs (including thymosin, interferon, interleukins, etc.) within the first 4 weeks prior to enrollment, or are still within 5 half-lives of such medications
- Have symptomatic central nervous system metastases (with stable brain metastases confirmed by imageology for more than 3 months were eligible)
- Severe infection ((≥CTCAE grade 2 infection) occurred within 4 weeks before the first dose of study drug, such as severe pneumonia requiring hospitalization, bacteremia, and infectious complications;Baseline chest imaging suggested active pulmonary inflammation with clinically relevant symptoms or signs;the presence of signs and symptoms of infection within 2 weeks before the first dose of the study drug ,or the need for treatment with oral or intravenous antibiotics was excluded if prophylactic antibiotics were used;
- Previous and current presence of interstitial pneumonia, pneumoconiosis, drug-related pneumonia, and severely impaired pulmonary function may interfere with the detection and management of suspected drug-related pulmonary toxicity in subjects;Subjects with radiation pneumonitis within 6 months
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- Had active pulmonary tuberculosis by medical history or CT examination, or who had a history of active pulmonary tuberculosis within 1 year before enrollment ,or who had a history of active pulmonary tuberculosis more than 1 year before enrollment but had not received regular treatment
- Congenital or acquired immune deficiency, such as human immunodeficiency virus (HIV) infection, active hepatitis B (HBV DNA ≥ 500 IU/ml), hepatitis C (hepatitis C antibody positive, and HCV-RNA above the detection limit of the assay) or co-infection with hepatitis B and C;
- Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation
- With thrombotic diseases or receiving anticoagulant drugs;
- Patients at risk of gastrointestinal hemorrhage or obstruction;
- Unable to swallow the experimental drug;
- Patients who have previously experienced immune-related myocarditis, pneumonitis, colitis, hepatitis, nephritis, etc.were judged to be at greater risk for immunotherapy retreatment by the investigator;
- Patients with complications who require long-term use of immunosuppressive drugs or those who need systemic or local administration of corticosteroids with immunosuppressive effects
- Patients considered unsuitable for inclusion in this study by the investigator
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
Medical Oncology,Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
About this study
Official title: Fruquintinib Combined With AK104 and Tegafur Gimeracial and Oteracil as Second-ine or After Line Treatment in Advanced or Metastatic ESCC
This is a prospective, single-arm, open-label，multi-center, phase Ib/II study, aiming to evaluate the efficacy and safety of Fruquintinib combined With Cadonilimab (AK104) and Tegafur，Gimeracil and Oteracil Potassium in patients with locally advanced or metastatic esophageal squamous cell carcinoma after the failure of first-line treatments.
Read the detailed description
Esophageal cancer is a malignant tumor with high incidence and death rate in the world, especially in china, and Esophageal squamous cell carcinoma (ESCC) is the main pathological type of esophageal carcinoma in China. Among patients with advanced or metastatic esophageal squamous cell carcinoma, the addition of immunotherapy to chemotherapy, compared with chemotherapy, significantly improved overall survival and progression-free survival in first-line treatments. Treatment of recurrent or metastatic esophageal squamous cell carcinoma is usually poor. New treatments were needed.Fruquintinib is an orally antiangiogenic agents, which target VEGFR1/2/3. Candonilimab (AK104) is a PD-1/CTLA-4 Bispecific Antibody. A combination of Fruquintinib and Candonilimab (AK104) and s-1 for advanced or metastatic esophageal squamous cell carcinoma could be a novel therapy. Therefore, investigators initialize this phase Ib/II study to explore the efficacy and safety of fruquintinib in combination with Candonilimab (AK104) and S-1 treatment in ESCC patients with after failure in 1st-line treatment.
In dose escalation period, 3-12 patients with Esophageal squamous cell carcinoma will be enrolled. Patients meeting enrollment eligibility will receive 21-day cycles of fruquintinib 2-3 mg qd，D1-14,Q3W； combined with Candonilimab 10 mg/kg，D1，Q3W and S-1 (30mg BID for body surface area <1.25 m2;40mg BID for body surface area ≥1.25 - <1.5 m2;50mg BID for body surface area ≥1.5m2 ；D1-14,Q3W)
Safety information will be collected till disease progression or intolerable toxicity to determine MTD and/or RPTD of fruquintinib combined with Candonilimab and S-1 in patients with Esophageal squamous cell carcinoma .
This period will include the following 2 dose groups from low to high:
A: Fruquintinib 2 mg qd for 2 weeks followed by 1-week break + Candonilimab 10 mg/kg，intravenous infusion，D1, every 3 weeks+ S-1 ,Calculate dosage based on body surface ,30mg for BSA <1.25 m2;40 mg for BSA ≥1.25 - <1.5 m2; 50mg for BSA ≥1.5m2;BID，D1-14，Q3W
B: Fruquintinib 3 mg qd for 2 weeks followed by 1-week break + Candonilimab 10 mg/kg，intravenous infusion，D1, every 3 weeks+ S-1 ,Calculate dosage based on body surface ,30mg for BSA <1.25 m2;40 mg for BSA ≥1.25 - <1.5 m2; 50mg for BSA ≥1.5m2;BID，D1-14，Q3W
This study will use traditional 3+3 trial design (3 subjects will be enrolled in each dose group first).
If 1 case of DLT is observed, additional 3 subjects will be enrolled in the same dose group,when no new DLTs occurred, the trial was continued to the next dose level to further evaluate toxicity ,to observe DLT and evaluate MTD.
If there are 2 or more cases of DLT in one dose group, the group lower than this dose group by one level is MTD dose group. If 2 dose group levels MTD was not reached, then the B group dose was RP2D.(DLT was predefined by the investigator in the protocol)
Subjects in the original dose group will continue to receive the next cycle of treatment at the original dose till disease progression or treatment withdrawal due to any of the following reasons: 1) death, 2) intolerable toxicity, 3) pregnancy, 4) the investigator considers the study should be terminated for the subject's best interests, 5) the subject or legal representative requests withdrawal, 6) loss to follow-up, 7) the subject has poor compliance and cannot comply with the study protocol.
In phase II period,patients meeting enrollment eligibility will receive Fruquintinib PR2D in combination with Candonilimab 10 mg/kg，intravenous infusion，D1, every 3 weeks and S-1 ,Calculate dosage based on body surface ,30mg for BSA <1.25 m2;40 mg for BSA ≥1.25 - <1.5 m2; 50mg for BSA ≥1.5m2;BID，D1-14，Q3W, till disease progression or treatment withdrawal due to any of the following reasons: 1) death, 2) intolerable toxicity, 3) pregnancy, 4) the investigator considers the study should be terminated for the subject's best interests, 5) the subject or legal representative requests withdrawal, 6) loss to follow-up, 7) the subject has poor compliance and cannot comply with the study protocol.
- Conditions
- Esophageal Squamous Cell Carcinoma
- Being tested
- fruquintinib++Candonilimab+ Tegafur，Gimeracil and Oteracil Potassium
- 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.
fruquintinib++Candonilimab+ Tegafur，Gimeracil and Oteracil PotassiumDrug
Fruquintinib administration for 2 weeks followed by 1-week break
Candonilimab：10 mg/kg，D1，Q3W；
Tegafur，Gimeracil and Oteracil Potassium：30mg BID for body surface area < 1.25 m2; 40mg BID for body surface area of 1.25-1.5 m2; and 50mg BID for body surface area >1.5 m2; D1-14, q3w
| Study group | Role | What they receive |
|---|---|---|
| Experimental:fruquintinib+Candonilimab + Tegafur，Gimeracil and Oteracil Potassium | Experimental | Fruquintinib administration for 2 weeks followed by 1-week break
Candonilimab：10 mg/kg，D1，Q3W；
Tegafur，Gimeracil and Oteracil Potassium：30mg BID for body surface area < 1.25 m2; 40mg BID for body surface area of 1.25-1.5 m2; and 50mg BID for body surface area >1.5 m2; D1-14, q3w Receives: Drug: fruquintinib++Candonilimab+ Tegafur，Gimeracil and Oteracil Potassium |
What is being measured
The primary outcome is the main question the study is designed to answer.
MTD and/or PR2D
To determine the Maximum Tolerated Dose ( MTD) and/or PR2D of fruquintinib combined with Cadonilimab and Tegafur,Gimeracil and Oteracil Porassium in patients with Esophageal squamous cell carcinoma (Phase Ib)
Measured: During the first 3 weeks
16-Week Progression-free Survival (PFS) Rate (Phase II)
16-Week Progression-free survival (PFS) rate is defined as the percentage of patients who are progression-free (stable disease, partial response, or complete response as defined by RECIST v1.1 criteria) at 16 weeks post registration
Measured: 16 week
Secondary outcomes (3)
Overall Response Rate (ORR) (Phase Ib）
from treatment up to progressive disease or EOT due to any cause up to 1 year
Measured: Tumor assessment will be performed using radiography method every 6 weeks until the occurrence of progressive disease (PD), using RECIST v 1.1
Disease control rate (DCR) (Phase Ib）
Tumor assessment will be performed using radiography method every 6 weeks until the occurrence of progressive disease (PD), using RECIST v 1.1
Measured: from treatment up to progressive disease or EOT due to any cause up to 1 year
Overall survival (OS) （Phase Ib)
Baseline to measured date of death from any cause
Measured: up to approximately 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2024
- Study start10 Jul 2024 (estimated)
- Primary completion10 Jun 2026 (estimated)
- Study completion10 Jun 2027 (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.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rui-hua Xu, MD, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rui-hua Xu, MD, PhD, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06487702
- Sponsor's protocol ID
- HMPL-013-FLAG-E102
- Status last verified
- Jun 2024
- First submitted
- 13 Jun 2024
- Last updated
- 5 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 5 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fruquintinib Combined With AK104 and Tegafur Gimeracial and Oteracil as Second-ine or After Line Treatment in Advanced or Metastatic ESCC
- ClinicalTrials.gov ID
- NCT06487702
- Acronym / sponsor ID
- HMPL-013-FLAG-E102
- Conditions
- Esophageal Squamous Cell Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Rui-hua Xu, MD, PhDUniversity, hospital or other
- Study start
- 10 Jul 2024 (estimated)
- Primary completion
- 10 Jun 2026 (estimated)
- Study completion
- 10 Jun 2027 (estimated)
- First posted
- 5 Jul 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.
This is a prospective, single-arm, open-label，multi-center, phase Ib/II study, aiming to evaluate the efficacy and safety of Fruquintinib combined With Cadonilimab (AK104) and Tegafur，Gimeracil and Oteracil Potassium in patients with locally advanced or metastatic esophageal squamous cell carcinoma after the failure of first-line treatments.
Detailed description
Esophageal cancer is a malignant tumor with high incidence and death rate in the world, especially in china, and Esophageal squamous cell carcinoma (ESCC) is the main pathological type of esophageal carcinoma in China. Among patients with advanced or metastatic esophageal squamous cell carcinoma, the addition of immunotherapy to chemotherapy, compared with chemotherapy, significantly improved overall survival and progression-free survival in first-line treatments. Treatment of recurrent or metastatic esophageal squamous cell carcinoma is usually poor. New treatments were needed.Fruquintinib is an orally antiangiogenic agents, which target VEGFR1/2/3. Candonilimab (AK104) is a PD-1/CTLA-4 Bispecific Antibody. A combination of Fruquintinib and Candonilimab (AK104) and s-1 for advanced or metastatic esophageal squamous cell carcinoma could be a novel therapy. Therefore, investigators initialize this phase Ib/II study to explore the efficacy and safety of fruquintinib in combination with Candonilimab (AK104) and S-1 treatment in ESCC patients with after failure in 1st-line treatment.
In dose escalation period, 3-12 patients with Esophageal squamous cell carcinoma will be enrolled. Patients meeting enrollment eligibility will receive 21-day cycles of fruquintinib 2-3 mg qd，D1-14,Q3W； combined with Candonilimab 10 mg/kg，D1，Q3W and S-1 (30mg BID for body surface area <1.25 m2;40mg BID for body surface area ≥1.25 - <1.5 m2;50mg BID for body surface area ≥1.5m2 ；D1-14,Q3W)
Safety information will be collected till disease progression or intolerable toxicity to determine MTD and/or RPTD of fruquintinib combined with Candonilimab and S-1 in patients with Esophageal squamous cell carcinoma .
This period will include the following 2 dose groups from low to high:
A: Fruquintinib 2 mg qd for 2 weeks followed by 1-week break + Candonilimab 10 mg/kg，intravenous infusion，D1, every 3 weeks+ S-1 ,Calculate dosage based on body surface ,30mg for BSA <1.25 m2;40 mg for BSA ≥1.25 - <1.5 m2; 50mg for BSA ≥1.5m2;BID，D1-14，Q3W
B: Fruquintinib 3 mg qd for 2 weeks followed by 1-week break + Candonilimab 10 mg/kg，intravenous infusion，D1, every 3 weeks+ S-1 ,Calculate dosage based on body surface ,30mg for BSA <1.25 m2;40 mg for BSA ≥1.25 - <1.5 m2; 50mg for BSA ≥1.5m2;BID，D1-14，Q3W
This study will use traditional 3+3 trial design (3 subjects will be enrolled in each dose group first).
If 1 case of DLT is observed, additional 3 subjects will be enrolled in the same dose group,when no new DLTs occurred, the trial was continued to the next dose level to further evaluate toxicity ,to observe DLT and evaluate MTD.
If there are 2 or more cases of DLT in one dose group, the group lower than this dose group by one level is MTD dose group. If 2 dose group levels MTD was not reached, then the B group dose was RP2D.(DLT was predefined by the investigator in the protocol)
Subjects in the original dose group will continue to receive the next cycle of treatment at the original dose till disease progression or treatment withdrawal due to any of the following reasons: 1) death, 2) intolerable toxicity, 3) pregnancy, 4) the investigator considers the study should be terminated for the subject's best interests, 5) the subject or legal representative requests withdrawal, 6) loss to follow-up, 7) the subject has poor compliance and cannot comply with the study protocol.
In phase II period,patients meeting enrollment eligibility will receive Fruquintinib PR2D in combination with Candonilimab 10 mg/kg，intravenous infusion，D1, every 3 weeks and S-1 ,Calculate dosage based on body surface ,30mg for BSA <1.25 m2;40 mg for BSA ≥1.25 - <1.5 m2; 50mg for BSA ≥1.5m2;BID，D1-14，Q3W, till disease progression or treatment withdrawal due to any of the following reasons: 1) death, 2) intolerable toxicity, 3) pregnancy, 4) the investigator considers the study should be terminated for the subject's best interests, 5) the subject or legal representative requests withdrawal, 6) loss to follow-up, 7) the subject has poor compliance and cannot comply with the study protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental:fruquintinib+Candonilimab + Tegafur，Gimeracil and Oteracil Potassium | Experimental | Drug: fruquintinib++Candonilimab+ Tegafur，Gimeracil and Oteracil PotassiumFruquintinib administration for 2 weeks followed by 1-week break Candonilimab：10 mg/kg，D1，Q3W； Tegafur，Gimeracil and Oteracil Potassium：30mg BID for body surface area < 1.25 m2; 40mg BID for body surface area of 1.25-1.5 m2; and 50mg BID for body surface area >1.5 m2; D1-14, q3w |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- age:18-75 years old, Male or female patients
- Histologically or cytologically confirmed esophageal squamous cell carcinoma (including the gastroesophageal junction), (Adenosquamous carcinoma with squamous cell carcinoma components-based is allowed to be included)
- Irretrievably resected, local advanced, relapsed or metastatic esophageal squamous cell carcinoma
- Previously received platinum-based systemic anti-tumor first-line therapy; Or received Neoadjuvant, adjuvant therapy, or radical chemoradiotherapy for ESCC, but disease recurrence or progression within 6 months after completion of treatment; no restrictions on prior immunotherapy treatment choice.
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 to 1
Key exclusion criteria (15 listed)
- Have had other malignancies within the past 5 years, except for curatively treated radical skin basal cell or squamous cell carcinoma, Or cervical carcinoma in situ;
- Have received major surgical procedures (such as craniotomy, thoracotomy, or laparotomy) within 4 weeks before enrollment or are excepted to uddergo major surgery during the study treatment; received laparoscopic exploration within 2 weeks before enrollment; received central venous catheterization within 7 days prior to enrollment
- Have received chemotherapy, targeted therapy, traditional Chinese herbal medicine with anti-tumor indications or immunomodulatory drugs (including thymosin, interferon, interleukins, etc.) within the first 4 weeks prior to enrollment, or are still within 5 half-lives of such medications
- Have symptomatic central nervous system metastases (with stable brain metastases confirmed by imageology for more than 3 months were eligible)
- Severe infection ((≥CTCAE grade 2 infection) occurred within 4 weeks before the first dose of study drug, such as severe pneumonia requiring hospitalization, bacteremia, and infectious complications;Baseline chest imaging suggested active pulmonary inflammation with clinically relevant symptoms or signs;the presence of signs and symptoms of infection within 2 weeks before the first dose of the study drug ,or the need for treatment with oral or intravenous antibiotics was excluded if prophylactic antibiotics were used;
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 |
|---|---|---|
| fruquintinib++Candonilimab+ Tegafur，Gimeracil and Oteracil PotassiumFruquintinib administration for 2 weeks followed by 1-week break Candonilimab：10 mg/kg，D1，Q3W； Tegafur，Gimeracil and Oteracil Potassium：30mg BID for body surface area < 1.25 m2; 40mg BID for body surface area of 1.25-1.5 m2; and 50mg BID for body surface area >1.5 m2; D1-14, q3w | Drug | Experimental:fruquintinib+Candonilimab + Tegafur，Gimeracil and Oteracil Potassium |
Primary outcome
MTD and/or PR2D
Time frame: During the first 3 weeks
To determine the Maximum Tolerated Dose ( MTD) and/or PR2D of fruquintinib combined with Cadonilimab and Tegafur,Gimeracil and Oteracil Porassium in patients with Esophageal squamous cell carcinoma (Phase Ib)
16-Week Progression-free Survival (PFS) Rate (Phase II)
Time frame: 16 week
16-Week Progression-free survival (PFS) rate is defined as the percentage of patients who are progression-free (stable disease, partial response, or complete response as defined by RECIST v1.1 criteria) at 16 weeks post registration
3 secondary outcomes
Overall Response Rate (ORR) (Phase Ib）
Time frame: Tumor assessment will be performed using radiography method every 6 weeks until the occurrence of progressive disease (PD), using RECIST v 1.1
Disease control rate (DCR) (Phase Ib）
Time frame: from treatment up to progressive disease or EOT due to any cause up to 1 year
Overall survival (OS) （Phase Ib)
Time frame: up to approximately 1 year
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 5 Jul 2024.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing fruquintinib++Candonilimab+ Tegafur，Gimeracil and Oteracil Potassium in people with Esophageal Squamous Cell Carcinoma, run by Rui-hua Xu, MD, PhD at 1 site in China.
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 11 inclusion and 15 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 5 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Hua R Xu, MD (13922206676, xurh@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MTD and/or PR2D (time frame: During the first 3 weeks). 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 5 Jul 2024.