Esophageal Squamous Cell CarcinomaPhase 3NCT06563869
Sintilimab With Chemotherapy Plus PEG-rhG-GSF for Neoadjuvant Treatment of Esophageal Squamous Cell Carcinoma
A Phase 3 study testing PEG-rhG-GSF in people with Esophageal Squamous Cell Carcinoma, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
This study is a prospective, open-label, single-arm, single-center clinical study, aiming to evaluate the efficacy and safety of sintilimab combined with platinum-based chemotherapy + pegylated recombinant human granulocyte stimulating factor as neoadjuvant treatment for resectable esophageal squamous cell carcinoma… 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?
- PEG-rhG-GSF
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 2 Feb 2024to 22 Nov 2026
- Phase
- Phase 3
- 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
- Voluntary signing of informed consent;
- Male or female, aged 18 years or above and 75 years or below;
- Patients diagnosed with esophageal squamous cell carcinoma by biopsy histopathological examination of the primary lesion; cervical metastasis was excluded by cervical B-ultrasound.
- Patients who were judged by imaging and endoscopic ultrasound examination to have potentially surgically resectable middle and lower esophagus (below 18 cm from the incisors) and require neoadjuvant therapy (T2-4aNxM0, stage II-IVA); for T2N0M0, the length of the primary tumor under endoscopic examination was required to be ≥ 2 cm, located below the neck, and ≥ 5 cm away from the cricopharyngeal muscle.
- Patients have not received any anti-tumor treatment in the past, including but not limited to surgery, radiotherapy, chemotherapy, immunotherapy, targeted therapy, etc.;
- The ECOG performance status score is 0-1;
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- Have adequate heart, lung, liver and kidney functions, and the laboratory tests within 14 days before screening meet the following indicators:
- Hemoglobin HB ≥ 90 g/L ii. Absolute neutrophil count ANC ≥ 1.5 × 109 /L iii. Platelet count PLT ≥ 80 × 109 /L iv. Albumin ALB ≥ 35 g/L v. Alanine aminotransferase ALT and aspartate aminotransferase AST ≤ 1.5 times the upper limit of the normal range vi. Total bilirubin ≤ 30 μmol/L vii. Creatinine SCr ≤ the upper limit of the normal range. viii. Coagulation: PT-INR ≤ 2.3 or PT < 6 seconds compared with the normal control
- Patients need to be able to complete the treatment and follow-up according to the research plan on schedule;
- Patients need to have sufficient tissue samples and agree to use their tissue samples and blood samples for research analysis;
- Pregnancy tests in women of childbearing age were negative and were willing to take effective contraceptive measures during the study.
Who cannot join
- Patients who may have tracheoesophageal fistula or aortic esophageal fistula;
- Patients with severe malnutrition or in need of tube feeding;
- Patients with other malignant tumors within 2 years and not cured (except for cured basal cell carcinoma of the skin and cervical carcinoma in situ);
- Patients with active autoimmune system diseases, or with a history of autoimmune system diseases or symptoms and in need of systemic hormone therapy or anti-autoimmune drug therapy;
- Patients with immunodeficiency, or still receiving systemic steroid hormone therapy (prednisone > 10 mg/day or other equivalent drugs) 7 days before the administration of the first dose of neoadjuvant therapy in this study, or other forms of immunosuppressive therapy;
- Patients with active infection and still in need of systemic treatment 7 days before the administration of the first dose of neoadjuvant therapy in this study;
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- Patients with uncontrollable systemic diabetes;
- Patients with interstitial lung disease, non-infectious pneumonia or pulmonary fibrosis;
- Patients with previous motor nerve or sensory nerve toxicity symptoms greater than WHO grade 1;
- Patients who have received allogeneic organ or stem cell transplantation in the past;
- Patients allergic to the drugs or related components involved in this study;
- Patients currently participating in other clinical studies;
- Patients who received anti-programmed death-1 (PD-1)/PD-1 ligand (PD-L1) monoclonal antibodies, cytotoxic T lymphocyte-associated antigen-4 (CTLA-4) antibodies or other immune or molecular targeted therapies within 4 weeks before screening;
- Patients with any serious or unstable medical conditions or mental illnesses;
- Patients with known active alcohol or drug abuse or dependence.
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, 1 recruiting
- Recruiting
the First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210029
Yanhong Gu, Ph.D, 13813908678, guluer@163.com
Yanhong Gu, Ph.D
About this study
Official title: Efficacy and Safety of Sintilimab in Combination With Platinum-containing Chemotherapy Plus PEG-rhG-GSF for Neoadjuvant Treatment of Esophageal Squamous Cell Carcinoma: a Prospective, Open, Single-arm, Single-center Clinical Study
This study is a prospective, open-label, single-arm, single-center clinical study, aiming to evaluate the efficacy and safety of sintilimab combined with platinum-based chemotherapy + pegylated recombinant human granulocyte stimulating factor as neoadjuvant treatment for resectable esophageal squamous cell carcinoma patients. In the study, all patients who meet the inclusion criteria will receive sintilimab combined with platinum-based chemotherapy for 2 cycles (21 days as one cycle) as neoadjuvant treatment according to the study plan. Pegylated recombinant human granulocyte stimulating factor will be given 24 hours after the end of chemotherapy, and radical surgical treatment will be received within 3-6 weeks after the completion of the last neoadjuvant treatment. Whether the subjects need adjuvant treatment after surgery and the adjuvant treatment plan will be determined by the investigators. All subjects need to complete the follow-up plan formulated by the study after surgery.
Read the detailed description
The patients selected for the study were those who were diagnosed with esophageal cancer for the first time. The recruited subjects should be:
- Preoperatively, the main part of the tumor was located in the middle and lower part of the esophagus (below 18 cm from the incisors) as shown by gastroscopy, and the pathological type was squamous cell carcinoma as shown by biopsy.
- Preoperatively, patients with esophageal cancer assessed by imaging (CT, MRI or PET/CT), cervical B-ultrasound and endoscopic ultrasound as potentially resectable. Potentially resectable patients were defined as those with T2-4aNxM0, stage II-IVA (AJCC staging, 8th edition, 2017) of esophageal cancer according to the 2022 Guidelines for the Diagnosis and Treatment of Esophageal Cancer of the Chinese Society of Clinical Oncology. For T2N0M0, the length of the primary tumor under endoscopic examination was required to be ≥ 2 cm, located below the neck, and ≥ 5 cm away from the cricopharyngeal muscle.
- Signed the informed consent form and met all the inclusion and exclusion criteria of this study.
- Conditions
- Esophageal Squamous Cell Carcinoma
- Being tested
- PEG-rhG-GSF
- Keywords
- esophageal squamous cell carcinoma, PEG-rhG-GSF
- 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.
PEG-rhG-GSFDrug
Also called Polyethylene glycolylated recombinant human granulocyte stimulating factor
Polyethylene glycolylated recombinant human granulocyte stimulating factor （6mg）will be given 24 hours after the end of chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant patients | Experimental | All subjects who meet the inclusion criteria will receive sintilimab combined with platinum-containing chemotherapy for 2 cycles (21 days for one cycle) as neoadjuvant therapy according to the research plan. Polyethylene glycolylated recombinant human granulocyte stimulating factor will be given 24 hours after the end of chemotherapy. Radical surgical treatment will be received within 3 to 6 weeks after the completion of the last neoadjuvant treatment. Receives: Drug: PEG-rhG-GSF |
What is being measured
The primary outcome is the main question the study is designed to answer.
pCR
The pathological complete response rate (pCR) after neoadjuvant therapy
Measured: Radical surgical treatment will be received within 3 to 6 weeks after the completion of the last neoadjuvant treatment.
Secondary outcomes (4)
MPR
major pathological response, MPR
Measured: Radical surgical treatment will be received within 3 to 6 weeks after the completion of the last neoadjuvant treatment.
RFS
Recurrence Free Survival
Measured: 5 years
R0 resection rate
The R0 resection rate after neoadjuvant therapy and subsequent surgery
Measured: Radical surgical treatment will be received within 3 to 6 weeks after the completion of the last neoadjuvant treatment.
AEs
New adjuvant therapy-related AEs
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2024
- Study start2 Feb 2024
- Primary completion22 Nov 2025 (estimated)
- Study completion22 Nov 2026 (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 The First Affiliated Hospital with Nanjing Medical 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All subjects who meet the inclusion criteria will receive sintilimab combined with platinum-containing chemotherapy for 2 cycles (21 days for 1 cycle) as neoadjuvant therapy according to the research plan. Polyethylene glycolylated recombinant human granulocyte stimulating factor will be given 24 hours after the end of chemotherapy. Radical surgical treatment will be received within 3-6 weeks after the completion of the last neoadjuvant treatment.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yanhong Gu, Ph.D., Study chair, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06563869
- Sponsor's protocol ID
- KEEP-G 12
- Status last verified
- Aug 2024
- First submitted
- 19 Aug 2024
- Last updated
- 21 Aug 2024
- Results posted
- 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 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Sintilimab in Combination With Platinum-containing Chemotherapy Plus PEG-rhG-GSF for Neoadjuvant Treatment of Esophageal Squamous Cell Carcinoma: a Prospective, Open, Single-arm, Single-center Clinical Study
- ClinicalTrials.gov ID
- NCT06563869
- Acronym / sponsor ID
- KEEP-G 12
- Conditions
- Esophageal Squamous Cell Carcinoma
- Keywords
- esophageal squamous cell carcinoma, PEG-rhG-GSF
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 2 Feb 2024 (actual)
- Primary completion
- 22 Nov 2025 (estimated)
- Study completion
- 22 Nov 2026 (estimated)
- First posted
- 21 Aug 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 study is a prospective, open-label, single-arm, single-center clinical study, aiming to evaluate the efficacy and safety of sintilimab combined with platinum-based chemotherapy + pegylated recombinant human granulocyte stimulating factor as neoadjuvant treatment for resectable esophageal squamous cell carcinoma patients. In the study, all patients who meet the inclusion criteria will receive sintilimab combined with platinum-based chemotherapy for 2 cycles (21 days as one cycle) as neoadjuvant treatment according to the study plan. Pegylated recombinant human granulocyte stimulating factor will be given 24 hours after the end of chemotherapy, and radical surgical treatment will be received within 3-6 weeks after the completion of the last neoadjuvant treatment. Whether the subjects need adjuvant treatment after surgery and the adjuvant treatment plan will be determined by the investigators. All subjects need to complete the follow-up plan formulated by the study after surgery.
Detailed description
The patients selected for the study were those who were diagnosed with esophageal cancer for the first time. The recruited subjects should be:
- Preoperatively, the main part of the tumor was located in the middle and lower part of the esophagus (below 18 cm from the incisors) as shown by gastroscopy, and the pathological type was squamous cell carcinoma as shown by biopsy.
- Preoperatively, patients with esophageal cancer assessed by imaging (CT, MRI or PET/CT), cervical B-ultrasound and endoscopic ultrasound as potentially resectable. Potentially resectable patients were defined as those with T2-4aNxM0, stage II-IVA (AJCC staging, 8th edition, 2017) of esophageal cancer according to the 2022 Guidelines for the Diagnosis and Treatment of Esophageal Cancer of the Chinese Society of Clinical Oncology. For T2N0M0, the length of the primary tumor under endoscopic examination was required to be ≥ 2 cm, located below the neck, and ≥ 5 cm away from the cricopharyngeal muscle.
- Signed the informed consent form and met all the inclusion and exclusion criteria of this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All subjects who meet the inclusion criteria will receive sintilimab combined with platinum-containing chemotherapy for 2 cycles (21 days for 1 cycle) as neoadjuvant therapy according to the research plan. Polyethylene glycolylated recombinant human granulocyte stimulating factor will be given 24 hours after the end of chemotherapy. Radical surgical treatment will be received within 3-6 weeks after the completion of the last neoadjuvant treatment.
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant patients | Experimental | Drug: PEG-rhG-GSFAll subjects who meet the inclusion criteria will receive sintilimab combined with platinum-containing chemotherapy for 2 cycles (21 days for one cycle) as neoadjuvant therapy according to the research plan. Polyethylene glycolylated recombinant human granulocyte stimulating factor will be given 24 hours after the end of chemotherapy. Radical surgical treatment will be received within 3 to 6 weeks after the completion of the last neoadjuvant treatment. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Voluntary signing of informed consent;
- Male or female, aged 18 years or above and 75 years or below;
- Patients diagnosed with esophageal squamous cell carcinoma by biopsy histopathological examination of the primary lesion; cervical metastasis was excluded by cervical B-ultrasound.
- Patients who were judged by imaging and endoscopic ultrasound examination to have potentially surgically resectable middle and lower esophagus (below 18 cm from the incisors) and require neoadjuvant therapy (T2-4aNxM0, stage II-IVA); for T2N0M0, the length of the primary tumor under endoscopic examination was required to be ≥ 2 cm, located below the neck, and ≥ 5 cm away from the cricopharyngeal muscle.
- Patients have not received any anti-tumor treatment in the past, including but not limited to surgery, radiotherapy, chemotherapy, immunotherapy, targeted therapy, etc.;
Key exclusion criteria (15 listed)
- Patients who may have tracheoesophageal fistula or aortic esophageal fistula;
- Patients with severe malnutrition or in need of tube feeding;
- Patients with other malignant tumors within 2 years and not cured (except for cured basal cell carcinoma of the skin and cervical carcinoma in situ);
- Patients with active autoimmune system diseases, or with a history of autoimmune system diseases or symptoms and in need of systemic hormone therapy or anti-autoimmune drug therapy;
- Patients with immunodeficiency, or still receiving systemic steroid hormone therapy (prednisone > 10 mg/day or other equivalent drugs) 7 days before the administration of the first dose of neoadjuvant therapy in this study, or other forms of immunosuppressive therapy;
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 |
|---|---|---|
| PEG-rhG-GSFAlso: Polyethylene glycolylated recombinant human granulocyte stimulating factorPolyethylene glycolylated recombinant human granulocyte stimulating factor （6mg）will be given 24 hours after the end of chemotherapy. | Drug | Neoadjuvant patients |
Primary outcome
pCR
Time frame: Radical surgical treatment will be received within 3 to 6 weeks after the completion of the last neoadjuvant treatment.
The pathological complete response rate (pCR) after neoadjuvant therapy
4 secondary outcomes
MPR
Time frame: Radical surgical treatment will be received within 3 to 6 weeks after the completion of the last neoadjuvant treatment.
RFS
Time frame: 5 years
R0 resection rate
Time frame: Radical surgical treatment will be received within 3 to 6 weeks after the completion of the last neoadjuvant treatment.
AEs
Time frame: 4 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 21 Aug 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.
Yanhong Gu, Ph.D. study chair
The First Affiliated Hospital with Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing PEG-rhG-GSF in people with Esophageal Squamous Cell Carcinoma, run by The First Affiliated Hospital with Nanjing Medical University 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: looking for participants now, as of the sponsor's last update on 21 Aug 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Yanhong Gu, Ph.D. (13813908678 ext. 025-68307881, guluer@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pCR (time frame: Radical surgical treatment will be received within 3 to 6 weeks after the completion of the last neoadjuvant treatment.). 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 21 Aug 2024.