Esophageal Squamous Cell CarcinomaPhase 2NCT06703047
Tislelizumab Combined with Chemotherapy and All Trans Retinoic Acid for Locally Advanced or Metastatic Esophageal Squamous Cell Carcinoma
A Phase 2 study testing ATRA+pd-1+chemo in people with Esophageal Squamous Cell Carcinoma, run by Fudan University.
Trial summary
Tislelizumab combined with chemotherapy and all trans retinoic acid for locally advanced or metastatic esophageal squamous cell carcinoma: a prospective, double-blind, multicenter, randomized controlled phase II trial Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Esophageal Squamous Cell Carcinoma
- What is being tested?
- ATRA+pd-1+chemo
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- 20 Nov 2024to 24 Oct 2030
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subjects voluntarily participate and sign a written informed consent form;
- Age ≥ 18 years old;
- Diagnosed by pathological histology as an inoperable locally advanced or metastatic esophageal squamous cell carcinoma patient;
- According to AJCC 8th edition staging and RECIST 1.1 solid tumor evaluation criteria, there must be at least one measurable lesion;
- Have not received any local or systemic anti-tumor treatment for locally advanced/metastatic esophageal squamous cell carcinoma. For patients who have received adjuvant/neoadjuvant chemotherapy, or radical radiotherapy for advanced diseases, if there is a gap of at least 6 months between disease progression or recurrence and the end of the last drug treatment, they are allowed to be included in this study;
- The main organs function is good;
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- Expected survival period ≥ 3 months;
- ECOG PS score: 0-1 points;
- According to the researcher's judgment, the patient has the ability to follow the research protocol.
- Non surgical sterilization or female patients of childbearing age are required to use a medically approved contraceptive measure (such as intrauterine device, contraceptive pill, or condom) during the study treatment period and within 6 months after the end of the study treatment period; Female patients of childbearing age who undergo non-surgical sterilization must have a negative serum or urine HCG test within 72 hours prior to enrollment in the study; And it must be during non lactation period; For male patients whose partners are women of childbearing age, effective contraception methods should be used during the trial period and within 6 months after the last dose.
Who cannot join
- Patients who have received immunotherapy;
- Individuals who are allergic to the drugs or their components used in this study;
- The patient currently (within 3 months) has digestive tract diseases such as esophageal varices, active ulcers of the stomach and duodenum, ulcerative colitis, portal hypertension, or other conditions determined by the researchers that may cause gastrointestinal bleeding or perforation;
- There are small cell carcinoma, adenocarcinoma, or mixed cancer components in histology;
- Central nervous system metastasis has occurred;
- Complete esophageal obstruction;
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- Unable to tolerate gastrointestinal endoscopic biopsy; Having clear concerns about gastrointestinal bleeding (such as local active ulcer lesions, positive fecal occult blood); History of gastrointestinal bleeding within 6 months;
- Patients with primary malignant tumors other than esophageal cancer (excluding cured skin basal cell carcinoma and cervical carcinoma in situ);
- Existence of any active autoimmune disease or history of autoimmune disease with expected recurrence;
- Discovering a high risk of esophageal fistula through clinical evaluation or imaging examinations, such as a history or related symptoms of esophageal fistula, or primary tumor infiltration into large blood vessels or trachea;
- If patients with uncontrolled tumor related pain require analgesic treatment, the treatment plan used at the time of enrollment in the study must be stable;
- Individuals who tested positive for HIV during screening;
- Individuals who test positive for hepatitis C virus (HCV) during screening;
- HBV positive and cccDNA ≥ 500 IU/mL during screening;
- Within the 6 months prior to enrollment, have any of the following diseases: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass surgery, symptomatic congestive heart failure, or cerebrovascular accident;
- Pregnant or lactating women or those who have the ability to conceive but have not taken contraceptive measures;
- Individuals with other serious acute or chronic physiological or mental problems;
- Participated in any other drug clinical studies within 4 weeks prior to the first administration
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: Tislelizumab Combined with Chemotherapy and All Trans Retinoic Acid for Locally Advanced or Metastatic Esophageal Squamous Cell Carcinoma: a Prospective, Double-blind, Multicenter, Randomized Controlled Phase II Trial
Tislelizumab combined with chemotherapy and all trans retinoic acid for locally advanced or metastatic esophageal squamous cell carcinoma: a prospective, double-blind, multicenter, randomized controlled phase II trial
Read the detailed description
This study is a prospective, double-blind, multicenter, randomized controlled phase II clinical trial of tislelizumab combined with chemotherapy and all trans retinoic acid in the treatment of locally advanced non-surgical or metastatic esophageal squamous cell carcinoma. The aim is to evaluate the efficacy and safety of tislelizumab combined with chemotherapy and all trans retinoic acid in the treatment of locally advanced non-surgical or metastatic esophageal squamous cell carcinoma. Patients with locally advanced inoperable or metastatic ESCC can only be enrolled after meeting the criteria. They will receive treatment with tislelizumab combined with chemotherapy+all trans retinoic acid or tislelizumab combined with chemotherapy+placebo, with a treatment cycle of every 3 weeks. The treatment will continue until disease progression or reaching the criteria for terminating the study drug treatment, for a maximum of two years.
- Conditions
- Esophageal Squamous Cell Carcinoma
- Being tested
- ATRA+pd-1+chemo, placebo+PD-1+chemo
- 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.
ATRA+pd-1+chemoDrug
All trans tretinoic acid+tislelizumab+chemotherapy (paclitaxel, cisplatin, or carboplatin)
placebo+PD-1+chemoDrug
Placebo+tislelizumab+chemotherapy (paclitaxel, cisplatin, or carboplatin)
| Study group | Role | What they receive |
|---|---|---|
| All trans tretinoic acid+tislelizumab+chemotherapy (paclitaxel, cisplatin, or carboplatin) | Experimental | Not described Receives: Drug: ATRA+pd-1+chemo |
| Placebo+tislelizumab+chemotherapy (paclitaxel, cisplatin, or carboplatin) | Placebo comparator | Not described Receives: Drug: placebo+PD-1+chemo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Measured: up to 3 years
Secondary outcomes (9)
Objective Response Rate
Measured: up to 3 years
Progression Free Survival
Measured: up to 3 years
Disease control rate
Measured: up to 3 years
Duration of Response
Measured: up to 3 years
Single cell TCR sequencing, whole exome sequencing, RNA seq, and methylation sequencing were performed on tumor tissue and blood samples
Measured: up to 3 years
Skin adverse reactions
Measured: up to 3 years
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Measured: up to 3 years
EORTC QLQ-30
Measured: up to 3 years
EORTC QLQ-LC13
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2024
- Study start20 Nov 2024 (estimated)
- Primary completion20 Nov 2029 (estimated)
- Study completion24 Oct 2030 (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 Fudan UniversityThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yu hui, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06703047
- Sponsor's protocol ID
- ESCC-ATRA-IIT-01
- Status last verified
- Nov 2024
- First submitted
- 23 Oct 2024
- Last updated
- 25 Nov 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 25 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tislelizumab Combined with Chemotherapy and All Trans Retinoic Acid for Locally Advanced or Metastatic Esophageal Squamous Cell Carcinoma: a Prospective, Double-blind, Multicenter, Randomized Controlled Phase II Trial
- ClinicalTrials.gov ID
- NCT06703047
- Acronym / sponsor ID
- ESCC-ATRA-IIT-01
- Conditions
- Esophageal Squamous Cell Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 20 Nov 2024 (estimated)
- Primary completion
- 20 Nov 2029 (estimated)
- Study completion
- 24 Oct 2030 (estimated)
- First posted
- 25 Nov 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.
Tislelizumab combined with chemotherapy and all trans retinoic acid for locally advanced or metastatic esophageal squamous cell carcinoma: a prospective, double-blind, multicenter, randomized controlled phase II trial
Detailed description
This study is a prospective, double-blind, multicenter, randomized controlled phase II clinical trial of tislelizumab combined with chemotherapy and all trans retinoic acid in the treatment of locally advanced non-surgical or metastatic esophageal squamous cell carcinoma. The aim is to evaluate the efficacy and safety of tislelizumab combined with chemotherapy and all trans retinoic acid in the treatment of locally advanced non-surgical or metastatic esophageal squamous cell carcinoma. Patients with locally advanced inoperable or metastatic ESCC can only be enrolled after meeting the criteria. They will receive treatment with tislelizumab combined with chemotherapy+all trans retinoic acid or tislelizumab combined with chemotherapy+placebo, with a treatment cycle of every 3 weeks. The treatment will continue until disease progression or reaching the criteria for terminating the study drug treatment, for a maximum of two years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| All trans tretinoic acid+tislelizumab+chemotherapy (paclitaxel, cisplatin, or carboplatin) | Experimental | Drug: ATRA+pd-1+chemo |
| Placebo+tislelizumab+chemotherapy (paclitaxel, cisplatin, or carboplatin) | Placebo comparator | Drug: placebo+PD-1+chemo |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- The subjects voluntarily participate and sign a written informed consent form;
- Age ≥ 18 years old;
- Diagnosed by pathological histology as an inoperable locally advanced or metastatic esophageal squamous cell carcinoma patient;
- According to AJCC 8th edition staging and RECIST 1.1 solid tumor evaluation criteria, there must be at least one measurable lesion;
- Have not received any local or systemic anti-tumor treatment for locally advanced/metastatic esophageal squamous cell carcinoma. For patients who have received adjuvant/neoadjuvant chemotherapy, or radical radiotherapy for advanced diseases, if there is a gap of at least 6 months between disease progression or recurrence and the end of the last drug treatment, they are allowed to be included in this study;
Key exclusion criteria (18 listed)
- Patients who have received immunotherapy;
- Individuals who are allergic to the drugs or their components used in this study;
- The patient currently (within 3 months) has digestive tract diseases such as esophageal varices, active ulcers of the stomach and duodenum, ulcerative colitis, portal hypertension, or other conditions determined by the researchers that may cause gastrointestinal bleeding or perforation;
- There are small cell carcinoma, adenocarcinoma, or mixed cancer components in histology;
- Central nervous system metastasis has occurred;
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 |
|---|---|---|
| ATRA+pd-1+chemoAll trans tretinoic acid+tislelizumab+chemotherapy (paclitaxel, cisplatin, or carboplatin) | Drug | All trans tretinoic acid+tislelizumab+chemotherapy (paclitaxel, cisplatin, or carboplatin) |
| placebo+PD-1+chemoPlacebo+tislelizumab+chemotherapy (paclitaxel, cisplatin, or carboplatin) | Drug | Placebo+tislelizumab+chemotherapy (paclitaxel, cisplatin, or carboplatin) |
Primary outcome
Overall Survival
Time frame: up to 3 years
9 secondary outcomes
Objective Response Rate
Time frame: up to 3 years
Progression Free Survival
Time frame: up to 3 years
Disease control rate
Time frame: up to 3 years
Duration of Response
Time frame: up to 3 years
Single cell TCR sequencing, whole exome sequencing, RNA seq, and methylation sequencing were performed on tumor tissue and blood samples
Time frame: up to 3 years
Skin adverse reactions
Time frame: up to 3 years
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: up to 3 years
EORTC QLQ-30
Time frame: up to 3 years
EORTC QLQ-LC13
Time frame: up to 3 years
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 25 Nov 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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ATRA+pd-1+chemo in people with Esophageal Squamous Cell Carcinoma, run by Fudan University.
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 10 inclusion and 18 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 25 Nov 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. Some participants in this study may receive a placebo. 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 Hui Yu, MD (86 13801725650, yhui30@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (time frame: up to 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 25 Nov 2024.