A Phase 2 interventional study of Toripalimab and Carboplatin + Paclitaxel in Esophageal Squamous Cell Carcinoma, sponsored by Vanderbilt-Ingram Cancer Center. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-09-23.
Sponsored by Vanderbilt-Ingram Cancer Center · Phase 2, Interventional, and Treatment
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Among 18 studies testing toripalimab in Esophageal Squamous Cell Carcinoma — 10 open to participants now, 11 under way, 4 of them phase 3. toripalimab · Esophageal Squamous Cell Carcinoma.
Among the 18 studies testing toripalimab in Esophageal Squamous Cell Carcinoma, this one is the 16th largest by planned enrollment, is one of 4 that started in 2026, is one of 13 in phase 2, reaches primary completion later than 10 of the 10 other live ones, and was the 18th registered.
676 studies on the registry are indexed under Esophageal Squamous Cell Carcinoma; 267 are open to participants now.
Browse Esophageal Squamous Cell Carcinoma studies →10 of the 18 studies testing toripalimab in Esophageal Squamous Cell Carcinoma are open now, in 3 countries. Recruiting first, the newest first:
Shanghai Junshi Bioscience Co., Ltd. · Sites in China
Ages 18–75
Tianjin Medical University Cancer Institute and Hospital · Sites in China
Ages 18–75
Sun Yat-sen University · Sites in China
Ages 18–75
Coherus Oncology, Inc. · Sites in United States, Taiwan
Ages 18+
Sun Yat-sen University · Sites in China
Ages 70–85
By country, each count listing its studies:
toripalimab: first FDA approval 2023 (LOQTORZI), first EMA approval 2024. What it is approved for, and how studies give it, is on its page →
Of the 180 Esophageal Squamous Cell Carcinoma studies recruiting now, 83 (46%) set no upper age limit and 76 (42%) stop at 75 or younger; 3 take children under 18; 8 take healthy volunteers.
This study: 18 Years to 100 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
18 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 1 · Phase 2 14 · Phase 3 4
First in 2019; this study’s year is marked. 4 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 20 is below the median of 64 across 563 interventional studies indexed under Esophageal Squamous Cell Carcinoma.
Median enrollment 69 across the 18 interventional studies. Of the 2 that completed or were terminated, 0 (0%) have results posted.
This tab as a report to print or save as PDF → With an account.
1 of 18 have an industry lead sponsor. The 10 most frequent:
Vanderbilt-Ingram Cancer Center is the lead sponsor of 223 studies on the registry; 33 are open to participants now.
Of its 23 completed or terminated interventional studies of FDA-regulated products, 18 (78%) have results posted.
Vanderbilt-Ingram Cancer Center has 2 studies filed under Esophageal Squamous Cell Carcinoma — fewer than ten, so there is no comparison to draw.
3 of the studies testing toripalimab in Esophageal Squamous Cell Carcinoma that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04848753Phase 3Shanghai Junshi Bioscience Co., Ltd.Perioperative Toripalimab (JS001) Combined With Neoadjuvant Chemotherapy in Patients With Resectable Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma | 2027-05-12 |
| NCT06187597Sun Yat-sen UniversityConsolidation of Toripalimab After Chemoradiotherapy in Elderly Esophageal Cancer (EC-CRT-007) | 2026-12-31 |
| NCT07484724Shanghai Junshi Bioscience Co., Ltd.A Study Evaluating the Safety and Efficacy of JS212 Combination Therapy in Patients With Advanced Esophageal Squamous Cell Carcinoma | 2027-06-30 |
Add all 3 to your calendar (.ics) → With an account.
Among the 18 studies testing toripalimab in Esophageal Squamous Cell Carcinoma, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This is a phase 2/window of opportunity study to determine the efficacy, by clinical complete response, and safety of induction toripalimab (PD-1 inhibitor) followed by definitive chemoradiotherapy (dCRT) and adjuvant toripalimab (up to one year) in patients with stage II - IVA ESCC. Tumor biopsies (tumor tissue, adjacent normal tissue), blood including ctDNA, and saliva will be obtained before, during, and after the induction phase. These tissues will be assessed for clinical and research associated markers and processes that may provide information regarding the role of toripalimab in tumor related processes.
Intravenous (IV) toripalimab infusions on Day 1 of each 21-day treatment cycle for 2 doses prior to dCRT followed by adjuvant toripalimab for up to 1 year. No toripalimab will be given during SOC dCRT.
After dCRT, all patients can progress to adjuvant toripalimab or resection followed by adjuvant toripalimab. After adjuvant toripalimab, routine surveillance will involve serial esophagogastroduodenoscopies (EGDs) and imaging.
Treatment will continue for up to an additional year with adjuvant toripalimab infusions, until disease progression, or intolerable toxicity. Patients will be followed for OS and subsequent anticancer therapy for up to 3 years after ending study treatment.
Note: Toripalimab will be provided to the study by Coherus. Each site will obtain carboplatin and paclitaxel from commercial supply to administer as standard of care.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Adequate organ and bone marrow function resulted ≤ 28 days prior to first dose of protocol-indicated treatment:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PD-1, PD-L1 and checkpoint inhibitors
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Intravenous (IV) toripalimab infusions on Day 1 of each 21-day treatment cycle for 2 doses prior to dCRT followed by adjuvant toripalimab for up to 1 year. No toripalimab will be given during SOC dCRT. After dCRT, all patients can progress to adjuvant toripalimab or resection followed by adjuvant toripalimab. After adjuvant toripalimab, routine surveillance will involve serial esophagogastroduodenoscopies (EGDs) and imaging. Treatment will continue for up to an additional year with adjuvant toripalimab infusions, until disease progression, or intolerable toxicity. Patients will be followed for OS and subsequent anticancer therapy for up to 3 years after ending study treatment. Note: Toripalimab will be provided to the study by Coherus. Each site will obtain carboplatin and paclitaxel from commercial supply to administer as standard of care.
Drug: Toripalimab · Drug: Carboplatin + Paclitaxel
Injection Q3W at 240mg doses
Also known as: Loqtorzi, toripalimab-tpzi
Drug pages: Carboplatin · Paclitaxel
Carboplatin AUC 2 Q1W Infusion, Paclitaxel Q1W Infusion 50mg/m2
Also known as: CarboTaxol, PC
To determine the clinical complete response rate to proportion of patients with complete clinical response (cCR) 4-12 weeks after completion of standard-of-care (SOC) dCRT.
Determine cCR score by achieving all of these:1 * No lesion, budding, or ulceration identified on esophagogastroduodenoscopy (EGD). * Bite-on-bite biopsies with no residual tumor. * EGD with endoscopic ultrasound (EUS) and fine needle aspiration (FNA) of suspicious lymph nodes (LNs) shows no residual tumor. If patients have suspicious LNs unable to be reached by FNA, they will not be classified as clinical complete responders.
Time frame: 4-11 weeks after completion of standard-of-care (SOC) dCRT.
To determine Disease-free survival (DFS
1, 2, and 3-year disease free survival rates defined as time from the start of treatment until disease recurrence, death from any cause, or the end of the study period if the patient does not experience recurrence.
Time frame: from start of treatment until 1, 2, and 3yrs post treatment
To determine Overall survival (OS)
2 and 3-year overall survival rates defined as the time from start of treatment until death from any cause, or the end of the study period/last follow up.
Time frame: from start of treatment until 2 and 3yrs post treatment
To determine frequency of Adverse Events (AEs)
AEs will be determined by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v6).
Time frame: through study completion, an average of 1 year
To determine Quality of life (QOL) measurements
The EORTC-QLQ-C30 questionnaire will be administered prior to toripalimab induction (during screening), after induction (post-induction assessment), after dCRT (post-CRT assessment), at EOT visit, and then at coinciding follow-up visits for up to 3 years. Uses scores from 0 to 100 for each part; High functional score means good health; High symptom score means high pain or trouble
Time frame: (during screening), after induction (post-induction assessment), after dCRT (post-CRT assessment), at EOT visit, and then at coinciding follow-up visits for up to 3 years
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Dec 2026; primary completion for Dec 2030, 48 months later.
Of 153 non-industry phase 2 interventional studies under Esophageal Squamous Cell Carcinoma, half reached primary completion within 41 months of starting (the median), counting those still running; a quarter within 30 and three quarters within 55. This study's planned 48 months is above that.
Counting every sponsor, half of 173 studies reached it within 40 months; a quarter within 28 and three quarters within 52.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Toripalimab
Esophageal Squamous Cell Carcinoma →
Vanderbilt-Ingram Cancer Center →