ESCCTCNCT04471480
TC Plus PD-1 Inhibitors Combined With Anlotinib for Advanced Advanced Esophageal Cancer
A study testing TC/PD-1 inhibitor/anlotinib in people with ESCC, run by Dong Wang at 1 site in China.
Trial summary
A Controlled Clinical Study of TC/PD-1 Inhibitors Combined With anlotinib as First-line Treatment for Advanced ESCC Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- ESCC
- What is being tested?
- TC/PD-1 inhibitor/anlotinib
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2020to 31 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Patients volunteered to participate in the study and signed the informed consent;
- Age 18-75, both male and female;
- Histologically or cytologically confirmed advanced or metastatic (stage IIIB, III C or IV) ESCC .
- At least one measurable lesion according to RECIST 1.1,which should not be treated locally, such as radiotherapy.
- ECOG PS 0-1- Page 3 of 5 [DRAFT] -
- Expected survival ≥ 3 months
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- Patients who never received systemic therapy in the past, including radiotherapy ,chemotherapy, targeted therapy and immunotherapy , or patients who relapsed more than 6 months after adjuvant chemotherapy.
- The main organ functions accorded with the following criteria within 7 days before treatment:
- (1)Blood routine examination ( without blood transfusion in 14 days): hemoglobin (HB) ≥ 90 g/L; neutrophil absolute value (ANC) ≥ 1.5 109/L; platelet (PLT) ≥80 109/L.
- Biochemical tests should meet the following criteria: 1) total bilirubin (TBIL) ≤1.5 times of upper limit of normal (ULN); 2) alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 *ULN, if accompanied by liver metastasis, ALT and AST ≤ 5* ULN; 3) serum creatinine (Cr) ≤ 1.5* ULN or creatinine clearance rate (CCr) ≥ 60 ml/min;4) Serum albumin (≥35g/L). (3) Doppler echocardiography: left ventricular ejection fraction (LVEF) ≥the low limit of normal value (50%).
- 9 Tissue samples should be provided for biomarker analysis (such as PD-L1 ) Patients who could not provide new tissues could provide 5-8 paraffin sections of 3-5 μm by archival preservation.
Who cannot join
- Severe allergic reactions to humanized antibodies or fusion proteins in the past
- known to have hypersensitivity to any component contained in Endostar or antibody preparations;
- Diagnosed of immunodeficiency or received systemic glucocorticoid therapy or any other form of immunosuppressive therapy within 14 days before the study, allowing physiological doses of glucocorticoids (≤10mg/day prednisone or equivalent);
- Patients with active, known or suspected autoimmune diseases. Patients with type I diabetes, hypothyroidism requiring hormone replacement therapy, skin disorders requiring no systemic treatment(such as vitiligo, psoriasis or alopecia). Patients who would not triggers can be included.
- Serious heart disease, include congestive heart failure, uncontrollable high-risk arrhythmia, unstable angina pectoris, myocardial infarction, and severe valvular disease.
- Patients treated targeted drugs such as bevacizumab, sunitinib, sorafenib, imatinib, famitinib, regiffenil, apatinib and anlotinib
Show all 10Show fewer
- Patients recieved systemic antineoplastic therapy, including cytotoxic therapy, signal transduction inhibitors, immunotherapy (or mitomycin C within 6 weeks before the grouping),recieved over-extended-field radiotherapy (EF-RT) within 4 weeks before the grouping or limited-field radiotherapy to evaluate the tumor lesions within 2 weeks before the grouping
- Positive hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus antibody (HCV Ab), indicating acute or chronic infection.
- Patients with active pulmonary tuberculosis (TB) infection judged by chest X-ray examination, sputum examination and clinical physical examination. Patients with active pulmonary tuberculosis infection in the previous year should be excluded even if they have been treated; Patients with active pulmonary tuberculosis infection more than a year ago should also be excluded unless the course and type of antituberculosis treatment previously were appropriate.
- Patients with brain metastases with symptoms or symptoms controlling less than 2 months
Trial locations and contacts
1 site in 1 country.
China1 site
Daping Hospital, Third Military Medical University
Chongqing, Chongqing Municipality, 400042
Dong Wang, PH.D., 86-23-68757151, dongwang64@hotmail.com
Dong Wang, PH.D.
About this study
Official title: Paclitaxel and Carboplatin Plus PD-1 Inhibitors Combined With Anlotinib for Advanced Esophageal Cancer(ESCC)
A Controlled Clinical Study of TC/PD-1 Inhibitors Combined With anlotinib as First-line Treatment for Advanced ESCC
Read the detailed description
The incidence rate of esophageal cancer is high in China and mainly squamous cell carcinoma. In recent years, although the level of surgery, radiotherapy and chemotherapy of esophageal cancer has improved, and studies have confirmed the role of anlotinib and PD-1 mAb in the posterior line treatment of esophageal squamous cell carcinoma, the prognosis of esophageal cancer is still not ideal. How to expand the clinical benefits of immunotherapy in esophageal cancer has become a research hotspot. Recent studies have shown that PD-1 mAb combined with other therapies with different mechanisms can improve the efficacy of immunotherapy. In the impawer150 study, platinum containing dual drug chemotherapy plus anti angiogenesis therapy combined with immunotherapy showed statistically and clinically significant PFS benefits in the first-line treatment of advanced non-small-cell lung cancer, which provides a new choice for the first-line treatment of advanced non-small-cell lung cancer. So far, there is no report on the first-line treatment of advanced esophageal squamous cell carcinoma with platinum containing dual drug chemotherapy plus anti angiogenesis drugs combined with immunotherapy. The purpose of this study is to evaluate the efficacy of cisplatin plus cisplatin in the treatment of advanced esophageal cancer.
- Conditions
- ESCC
- Being tested
- TC/PD-1 inhibitor/anlotinib
- Keywords
- PD-1, anlotinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TC/PD-1 inhibitor/anlotinibDrug
Also called TC/PD-1 inhibitor
chemotherapy and immunotherapy plus antiangiogenic therapy
| Study group | Role | What they receive |
|---|---|---|
| group A，TCCA | Experimental | paclitaxel for Injection 175 mg/m2,IV, d1/paclitaxel for Injection (Albumin Bound) 260mg/m2,IV, d1, q3w +carboplatin AUC 4-6,IV, d12,q3w +anlotinib 10mg, PO, d1-14, q3w +camrelizumab 200 mg, IV, d1, q3w, after the treatment for 4-6 cycles, camrelizumab plus anlotinib for maintenance therapy until PD or intolerable toxicity Receives: Drug: TC/PD-1 inhibitor/anlotinib |
| group B，TCC | Experimental | paclitaxel for Injection 175 mg/m2,IV, d1/paclitaxel for Injection (Albumin Bound) 260mg/m2,IV, d1, q3w +carboplatin AUC 4-6,IV, d12,q3w +camrelizumab 200 mg, IV, d1, q3w, after the treatment for 4-6 cycles, camrelizumab for maintenance therapy until PD or intolerable toxicity Receives: Drug: TC/PD-1 inhibitor/anlotinib |
| group C，TC | Other | paclitaxel for Injection 175 mg/m2,IV, d1/paclitaxel for Injection (Albumin Bound) 260mg/m2,IV, d1, q3w +carboplatin AUC 4-6,IV, d12,q3w Receives: Drug: TC/PD-1 inhibitor/anlotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
objective response rate(ORR)
complete response(CR)+partial response(PR) according to RECIST 1.1
Measured: approximately 18 months
overall survival (OS)
overall survival is defined as the time from randomization to death from any cause
Measured: approximately 36 months
Secondary outcomes (1)
progression-free survival(PFS)
progression-free survival is defined as the time from enrollment to the date of first document disease progression or death from any cause
Measured: approximately 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2020
- Study start1 Sep 2020 (estimated)
- Primary completion31 Aug 2022 (estimated)
- Study completion31 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ESCCStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dong Wang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dong Wang, Third Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04471480
- Sponsor's protocol ID
- TCAC-ESCC-01
- Acronym
- TC
- Status last verified
- Jul 2020
- First submitted
- 12 Jul 2020
- Last updated
- 15 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Xu M, Pu Y, Jiang Y, Liu Y, Feng Y, Zhao X, Li M. Anlotinib plus camrelizumab and chemotherapy as first-line treatment in patients with advanced esophageal squamous cell carcinoma. Sci Rep. 2025 Jul 1;15(1):22275. doi: 10.1038/s41598-025-06625-2.
PubMed 40595001
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Paclitaxel and Carboplatin Plus PD-1 Inhibitors Combined With Anlotinib for Advanced Esophageal Cancer(ESCC)
- ClinicalTrials.gov ID
- NCT04471480
- Acronym / sponsor ID
- TC / TCAC-ESCC-01
- Conditions
- ESCC
- Keywords
- PD-1, anlotinib
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Dong WangUniversity, hospital or other
- Study start
- 1 Sep 2020 (estimated)
- Primary completion
- 31 Aug 2022 (estimated)
- Study completion
- 31 Aug 2023 (estimated)
- First posted
- 15 Jul 2020 (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.
A Controlled Clinical Study of TC/PD-1 Inhibitors Combined With anlotinib as First-line Treatment for Advanced ESCC
Detailed description
The incidence rate of esophageal cancer is high in China and mainly squamous cell carcinoma. In recent years, although the level of surgery, radiotherapy and chemotherapy of esophageal cancer has improved, and studies have confirmed the role of anlotinib and PD-1 mAb in the posterior line treatment of esophageal squamous cell carcinoma, the prognosis of esophageal cancer is still not ideal. How to expand the clinical benefits of immunotherapy in esophageal cancer has become a research hotspot. Recent studies have shown that PD-1 mAb combined with other therapies with different mechanisms can improve the efficacy of immunotherapy. In the impawer150 study, platinum containing dual drug chemotherapy plus anti angiogenesis therapy combined with immunotherapy showed statistically and clinically significant PFS benefits in the first-line treatment of advanced non-small-cell lung cancer, which provides a new choice for the first-line treatment of advanced non-small-cell lung cancer. So far, there is no report on the first-line treatment of advanced esophageal squamous cell carcinoma with platinum containing dual drug chemotherapy plus anti angiogenesis drugs combined with immunotherapy. The purpose of this study is to evaluate the efficacy of cisplatin plus cisplatin in the treatment of advanced esophageal cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| group A，TCCA | Experimental | Drug: TC/PD-1 inhibitor/anlotinibpaclitaxel for Injection 175 mg/m2,IV, d1/paclitaxel for Injection (Albumin Bound) 260mg/m2,IV, d1, q3w +carboplatin AUC 4-6,IV, d12,q3w +anlotinib 10mg, PO, d1-14, q3w +camrelizumab 200 mg, IV, d1, q3w, after the treatment for 4-6 cycles, camrelizumab plus anlotinib for maintenance therapy until PD or intolerable toxicity |
| group B，TCC | Experimental | Drug: TC/PD-1 inhibitor/anlotinibpaclitaxel for Injection 175 mg/m2,IV, d1/paclitaxel for Injection (Albumin Bound) 260mg/m2,IV, d1, q3w +carboplatin AUC 4-6,IV, d12,q3w +camrelizumab 200 mg, IV, d1, q3w, after the treatment for 4-6 cycles, camrelizumab for maintenance therapy until PD or intolerable toxicity |
| group C，TC | Other | Drug: TC/PD-1 inhibitor/anlotinibpaclitaxel for Injection 175 mg/m2,IV, d1/paclitaxel for Injection (Albumin Bound) 260mg/m2,IV, d1, q3w +carboplatin AUC 4-6,IV, d12,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)
- Patients volunteered to participate in the study and signed the informed consent;
- Age 18-75, both male and female;
- Histologically or cytologically confirmed advanced or metastatic (stage IIIB, III C or IV) ESCC .
- At least one measurable lesion according to RECIST 1.1,which should not be treated locally, such as radiotherapy.
- ECOG PS 0-1- Page 3 of 5 [DRAFT] -
Key exclusion criteria (10 listed)
- Severe allergic reactions to humanized antibodies or fusion proteins in the past
- known to have hypersensitivity to any component contained in Endostar or antibody preparations;
- Diagnosed of immunodeficiency or received systemic glucocorticoid therapy or any other form of immunosuppressive therapy within 14 days before the study, allowing physiological doses of glucocorticoids (≤10mg/day prednisone or equivalent);
- Patients with active, known or suspected autoimmune diseases. Patients with type I diabetes, hypothyroidism requiring hormone replacement therapy, skin disorders requiring no systemic treatment(such as vitiligo, psoriasis or alopecia). Patients who would not triggers can be included.
- Serious heart disease, include congestive heart failure, uncontrollable high-risk arrhythmia, unstable angina pectoris, myocardial infarction, and severe valvular disease.
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 |
|---|---|---|
| TC/PD-1 inhibitor/anlotinibAlso: TC/PD-1 inhibitorchemotherapy and immunotherapy plus antiangiogenic therapy | Drug | group A，TCCA, group B，TCC, group C，TC |
Primary outcome
objective response rate(ORR)
Time frame: approximately 18 months
complete response(CR)+partial response(PR) according to RECIST 1.1
overall survival (OS)
Time frame: approximately 36 months
overall survival is defined as the time from randomization to death from any cause
1 secondary outcome
progression-free survival(PFS)
Time frame: approximately 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2020.
- Derived from this study: PubMed 40595001Xu M, Pu Y, Jiang Y, Liu Y, Feng Y, Zhao X, Li M. Anlotinib plus camrelizumab and chemotherapy as first-line treatment in patients with advanced esophageal squamous cell carcinoma. Sci Rep. 2025 Jul 1;15(1):22275. doi: 10.1038/s41598-025-06625-2.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TC/PD-1 inhibitor/anlotinib in people with ESCC, run by Dong Wang 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 10 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: status not confirmed, as of the sponsor's last update on 15 Jul 2020. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dong Wang, PH.D (86-23-68757181, dongwang64@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
objective response rate(ORR) (time frame: approximately 18 months). 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?
On the ClinicalTrials.gov record for NCT04471480, which also lists 1 linked publication.
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 15 Jul 2020.