Tislelizumab Combined with Chemotherapy and All Trans Retinoic Acid for Locally Advanced or Metastatic Esophageal Squamous Cell Carcinoma

NCT06703047 | Not Yet Recruiting Phase 2

• 1 other identifier: ESCC-ATRA-IIT-01
• Study Type: interventional
• Target: 180
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Esophageal Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  up to 3 years

Secondary Outcomes (9)

• Objective Response Rate

  up to 3 years

• Progression Free Survival

  up to 3 years

• Disease control rate

  up to 3 years

• Duration of Response

  up to 3 years

• Single cell TCR sequencing, whole exome sequencing, RNA seq, and methylation sequencing were performed on tumor tissue and blood samples

  up to 3 years

Study Arms (2)

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

Interventions

ATRA+pd-1+chemo DRUG

All trans tretinoic acid+tislelizumab+chemotherapy (paclitaxel, cisplatin, or carboplatin)

All trans tretinoic acid+tislelizumab+chemotherapy (paclitaxel, cisplatin, or carboplatin)

placebo+PD-1+chemo DRUG

Placebo+tislelizumab+chemotherapy (paclitaxel, cisplatin, or carboplatin)

Placebo+tislelizumab+chemotherapy (paclitaxel, cisplatin, or carboplatin)

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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.

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Fudan University: lead

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Central Study Contacts

Hui Yu, MD

CONTACT

86 13801725650; yhui30@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: October 23, 2024
• First Posted: November 25, 2024
• Study Start: November 20, 2024
• Primary Completion (Estimated): November 20, 2029
• Study Completion (Estimated): October 24, 2030
• Last Updated: November 25, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share