Resectable Esophageal CancerPhase 2FAIRNCT07385664
Neoadjuvant Chemoimmunotherapy or Chemoradiotherapy in ESCC
A Phase 2 study testing Neoadjuvant Chemoimmunotherapy or Concurrent Chemoradiotherapy in people with Resectable Esophageal Cancer, run by Ji Yongling at 1 site in China.
Trial summary
This study was a single-arm, two-cohort, phase II trial aimed at evaluating the efficacy and safety of FAPI-PET/CT response for guiding the selection of neoadjuvant treatment modes after chemotherapy combined with immunotherapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Resectable Esophageal Cancer
- What is being tested?
- Neoadjuvant Chemoimmunotherapy or Concurrent Chemoradiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteChina
- Study dates
- 28 Jan 2026to 1 Feb 2028
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be able to understand and voluntarily provide written informed consent before any procedures required for the study are performed.
- Age between 18 and 75 years.
- Eastern Cooperative Oncology Group (ECOG) performance status score 0-1.
- Histologically confirmed esophageal squamous cell carcinoma.
- T1N1-3M0 or T2-4aNanyM0 as determined by endoscopic ultrasound (EUS) or magnetic resonance imaging (MRI) and PET/CT. All lesions, including tumor and lymph nodes, were required to be resectable.
- Tumors with strong FAPI uptake on baseline PET/CT scan should have a maximum standardized uptake value (SUVmax) ≥5.0.
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- Subjects were required to provide preoperative paraffin blocks or white slides of tumor tissue, or freshly collected samples, including at least 3 unstained FFPE pathological slides.
- Female subjects of childbearing potential must have a urine or serum pregnancy test with a negative result within 3 days before the first dose. If urine testing could not confirm the negative result, serum testing was required. Participants who had sex with an unsterilized male partner were required to use an effective contraceptive method from the time of screening and to agree to continue using a contraceptive method for 120 days after the last dose. Discontinuation of contraception after 120 days was discussed with the investigator.
- Unsterilized male subjects who have sex with a female partner of childbearing potential are required to use effective contraception from the time of screening until 120 days after the last dose; Discontinuation of contraception after 120 days is also discussed with the investigator.
- Laboratory tests must meet the following criteria:
- Absolute neutrophil count (ANC) ≥ 1500 /µL Platelet count ≥ 100,000/µL Total bilirubin ≤ 2.5 times the upper limit of normal Creatinine clearance (calculated by the following formula) ≥ 60 mL/ minute AST/ALT ≤ 1.5 times the upper limit of normal The modified Cockcroft-Gault equation was used to estimate creatinine clearance (Clcr) :
- For serum creatinine concentration (Sr Cr) expressed in mg/dL:
- Clcr (mL/min) = (140-age) × actual weight (kg)/(72 × Sr Cr(mg/dL)) Results for women were calculated using 85% of the Clcr values for men.
Who cannot join
- A history of malignant tumors within the past five years prior to registration (excluding basal cell carcinoma, squamous cell skin cancer, carcinoma in situ of the bladder, or cervical cancer). Patients who have undergone surgical treatment and have remained disease-free for over five years are still eligible for inclusion.
- Known contraindications include severe allergic reactions to taxanes, platinum-based drugs, 5-FU medications, etc.
- Patients with a documented history of severe allergic reactions to sintilimab.
- Patients who are unwilling or unable to adhere to visit schedules, treatment plans, laboratory tests, and other study requirements.
- Previous radiotherapy administered to the chest or abdomen.
- Patients who have received treatments involving platinum agents, taxanes, 5-FU drugs or PD-1 inhibitors.
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- T4 stage tumors exhibiting definite invasion into the spine, heart, major blood vessels or tracheobronchial tree.
- Patients with confirmed cervical or supraclavicular lymph node metastasis or other metastatic lymph nodes that cannot be included in the radiotherapy field nor removed during esophagectomy.
- Patients diagnosed with distant metastases through PET/CT scans or other examinations indicating liver, lung or bone metastases.
- Individuals suffering from significant uncontrolled cardiovascular diseases (such as heart failure), severe coronary artery disease or recent myocardial infarction; also includes those with serious conditions affecting liver or kidney function (e.g., renal insufficiency or liver cirrhosis).
- History of severe central nervous system disorders or mental health issues that may impact treatment compliance and study monitoring.
- Individuals presenting severe surgical contraindications that render them unable to tolerate surgery.
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
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
Kaiyi Tao, M.D, 13867112921, taoky@zjcc.org.cn
About this study
Official title: A Phase II Study of Neoadjuvant Chemoimmunotherapy or Concurrent Chemoradiotherapy Guided by Post-Chemoimmunotherapy FAPI-PET/CT
This study was a single-arm, two-cohort, phase II trial aimed at evaluating the efficacy and safety of FAPI-PET/CT response for guiding the selection of neoadjuvant treatment modes after chemotherapy combined with immunotherapy.
Read the detailed description
After signing the informed consent form, patients initially underwent two cycles of neoadjuvant chemotherapy in combination with immunotherapy. The chemotherapy protocol consisted of albumin-bound paclitaxel (260mg/m2, with a maximum dose of 400mg) + carboplatin (AUC = 5). Sintilimab was employed for immunotherapy at a fixed dose of 200mg.
FAPI-PET/CT was carried out between days 15 and 22 following two cycles of chemoimmunotherapy. If the FAPI-PET/CT results indicated that the SUVmax of the primary tumor decreased by more than 53%, the patient was included in the response cohort and continued to receive one or two cycles of neoadjuvant chemotherapy combined with immunotherapy after day 22 after the second chemotherapy, every 3 cycles. The chemotherapy and immunotherapy regimens were the same as those in the first and second cycles. After the completion of three to four cycles of chemotherapy combined with immunotherapy, CT was reviewed, and the resectability was evaluated by surgery. For operable patients, surgical resection would be performed within 4 to 6 weeks.
If the FAPI-PET/CT results indicated that the SUVmax of the primary lesion decreased by less than 53%, remained unaltered or even increased, the patient was included in the non-response cohort and received concurrent chemoradiotherapy. At the 4th week of concurrent chemoradiotherapy (18 - 23 fractions of radiotherapy), the resectability was assessed through surgery. For operable patients, surgical resection would be carried out within 4 to 6 weeks after the completion of chemoradiotherapy.
Patients who failed to achieve pCR after surgery will receive adjuvant sintilimab at a dose of 200mg every 3 weeks for one year.
The pCR rate, MPR rate, DFS, OS, FAPI-PET/CT response rate, incidence of postoperative anastomotic leakage, incidence of pneumonia, and quality of life evaluation were observed in patients with or without FAPI response. Meanwhile, the correlation between PD-L1 expression level and PET/CT response was explored, and the feasibility of FAPI-PET/CT response in guiding the selection of neoadjuvant therapy was evaluated.
- Conditions
- Resectable Esophageal Cancer
- Being tested
- Neoadjuvant Chemoimmunotherapy or Concurrent Chemoradiotherapy
- Keywords
- FAPI-PET/CT, Resectable Esophageal Cancer, Neoadjuvant Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neoadjuvant Chemoimmunotherapy or Concurrent ChemoradiotherapyCombination product
FAPI-PET/CT was carried out between days 15 and 22 after two cycles of chemoimmunotherapy. If the FAPI-PET/CT results indicated that the SUVmax of the primary lesion decreased by more than 53%, the patient was included in the response cohort. If the FAPI-PET/CT results showed that the SUVmax of the primary lesion decreased by less than 53%, remained unchanged or even increased, the patient was placed in the non-response cohort and received concurrent chemoradiotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Chemotherapy + PD-1 inhibitor | Experimental | Patients initially received two cycles of neoadjuvant chemotherapy in combination with immunotherapy. The chemotherapy protocol consisted of albumin-bound paclitaxel (260mg/m2, with a maximum dose of 400mg) + carboplatin (AUC=5). Sintilimab was employed for immunotherapy at a fixed dose of 200mg. Receives: Combination Product: Neoadjuvant Chemoimmunotherapy or Concurrent Chemoradiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
pCR
Based on the FAPI-PET/CT responders after chemoradiotherapy, the pCR rate of the continued neoadjuvant chemoradiotherapy was over 44%
Measured: up to 12 weeks
pCR
Patients with a poor FAPI-PET/CT response after chemoradiotherapy were shifted to concurrent chemoradiotherapy, and the pCR rate was no less than 22%.
Measured: up to 12 weeks
Secondary outcomes (4)
MPR
The MPR rate of patients responding to neoadjuvant chemoradiotherapy and FAPI-PET/CT after chemoradiotherapy was based on the MPR rate of patients who continued neoadjuvant chemoradiotherapy, and the MPR rate of patients with a poor FAPI-PET/CT response was converted to concurrent chemoradiotherapy.
Measured: up to 12 weeks
DFS
Disease-free survival. Patients responding to neoadjuvant chemoradiotherapy based on FAPI-PET/CT after chemoradiotherapy had a higher 1-year DFS rate than those not responding.
Measured: 1 year
OS
Overall survival
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
FAPI-PET/CT response rate
The proportion of patients with a change in tumor metabolic activity ≥53% (PET/CT response rate) was evaluated by comparing PFAPI-ET/CT results after chemoradiotherapy as an early predictor of response.
Measured: At the end of Cycle 2(each cycle is 21 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2026
- Study start28 Jan 2026 (estimated)
- Primary completion30 Jan 2027 (estimated)
- Study completion1 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Resectable Esophageal CancerStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ji Yongling
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ji Yongling, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07385664
- Sponsor's protocol ID
- IRB-2025-424
- Acronym
- FAIR
- Status last verified
- Jan 2026
- First submitted
- 20 May 2025
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Privacy
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Neoadjuvant Chemoimmunotherapy or Concurrent Chemoradiotherapy Guided by Post-Chemoimmunotherapy FAPI-PET/CT
- ClinicalTrials.gov ID
- NCT07385664
- Acronym / sponsor ID
- FAIR / IRB-2025-424
- Conditions
- Resectable Esophageal Cancer
- Keywords
- FAPI-PET/CT, Resectable Esophageal Cancer, Neoadjuvant Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Ji YonglingUniversity, hospital or other
- Study start
- 28 Jan 2026 (estimated)
- Primary completion
- 30 Jan 2027 (estimated)
- Study completion
- 1 Feb 2028 (estimated)
- First posted
- 4 Feb 2026 (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 was a single-arm, two-cohort, phase II trial aimed at evaluating the efficacy and safety of FAPI-PET/CT response for guiding the selection of neoadjuvant treatment modes after chemotherapy combined with immunotherapy.
Detailed description
After signing the informed consent form, patients initially underwent two cycles of neoadjuvant chemotherapy in combination with immunotherapy. The chemotherapy protocol consisted of albumin-bound paclitaxel (260mg/m2, with a maximum dose of 400mg) + carboplatin (AUC = 5). Sintilimab was employed for immunotherapy at a fixed dose of 200mg.
FAPI-PET/CT was carried out between days 15 and 22 following two cycles of chemoimmunotherapy. If the FAPI-PET/CT results indicated that the SUVmax of the primary tumor decreased by more than 53%, the patient was included in the response cohort and continued to receive one or two cycles of neoadjuvant chemotherapy combined with immunotherapy after day 22 after the second chemotherapy, every 3 cycles. The chemotherapy and immunotherapy regimens were the same as those in the first and second cycles. After the completion of three to four cycles of chemotherapy combined with immunotherapy, CT was reviewed, and the resectability was evaluated by surgery. For operable patients, surgical resection would be performed within 4 to 6 weeks.
If the FAPI-PET/CT results indicated that the SUVmax of the primary lesion decreased by less than 53%, remained unaltered or even increased, the patient was included in the non-response cohort and received concurrent chemoradiotherapy. At the 4th week of concurrent chemoradiotherapy (18 - 23 fractions of radiotherapy), the resectability was assessed through surgery. For operable patients, surgical resection would be carried out within 4 to 6 weeks after the completion of chemoradiotherapy.
Patients who failed to achieve pCR after surgery will receive adjuvant sintilimab at a dose of 200mg every 3 weeks for one year.
The pCR rate, MPR rate, DFS, OS, FAPI-PET/CT response rate, incidence of postoperative anastomotic leakage, incidence of pneumonia, and quality of life evaluation were observed in patients with or without FAPI response. Meanwhile, the correlation between PD-L1 expression level and PET/CT response was explored, and the feasibility of FAPI-PET/CT response in guiding the selection of neoadjuvant therapy was evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chemotherapy + PD-1 inhibitor | Experimental | Combination Product: Neoadjuvant Chemoimmunotherapy or Concurrent ChemoradiotherapyPatients initially received two cycles of neoadjuvant chemotherapy in combination with immunotherapy. The chemotherapy protocol consisted of albumin-bound paclitaxel (260mg/m2, with a maximum dose of 400mg) + carboplatin (AUC=5). Sintilimab was employed for immunotherapy at a fixed dose of 200mg. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Be able to understand and voluntarily provide written informed consent before any procedures required for the study are performed.
- Age between 18 and 75 years.
- Eastern Cooperative Oncology Group (ECOG) performance status score 0-1.
- Histologically confirmed esophageal squamous cell carcinoma.
- T1N1-3M0 or T2-4aNanyM0 as determined by endoscopic ultrasound (EUS) or magnetic resonance imaging (MRI) and PET/CT. All lesions, including tumor and lymph nodes, were required to be resectable.
Key exclusion criteria (12 listed)
- A history of malignant tumors within the past five years prior to registration (excluding basal cell carcinoma, squamous cell skin cancer, carcinoma in situ of the bladder, or cervical cancer). Patients who have undergone surgical treatment and have remained disease-free for over five years are still eligible for inclusion.
- Known contraindications include severe allergic reactions to taxanes, platinum-based drugs, 5-FU medications, etc.
- Patients with a documented history of severe allergic reactions to sintilimab.
- Patients who are unwilling or unable to adhere to visit schedules, treatment plans, laboratory tests, and other study requirements.
- Previous radiotherapy administered to the chest or abdomen.
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 |
|---|---|---|
| Neoadjuvant Chemoimmunotherapy or Concurrent ChemoradiotherapyFAPI-PET/CT was carried out between days 15 and 22 after two cycles of chemoimmunotherapy. If the FAPI-PET/CT results indicated that the SUVmax of the primary lesion decreased by more than 53%, the patient was included in the response cohort. If the FAPI-PET/CT results showed that the SUVmax of the primary lesion decreased by less than 53%, remained unchanged or even increased, the patient was placed in the non-response cohort and received concurrent chemoradiotherapy. | Combination product | Chemotherapy + PD-1 inhibitor |
Primary outcome
pCR
Time frame: up to 12 weeks
Based on the FAPI-PET/CT responders after chemoradiotherapy, the pCR rate of the continued neoadjuvant chemoradiotherapy was over 44%
pCR
Time frame: up to 12 weeks
Patients with a poor FAPI-PET/CT response after chemoradiotherapy were shifted to concurrent chemoradiotherapy, and the pCR rate was no less than 22%.
4 secondary outcomes
MPR
Time frame: up to 12 weeks
DFS
Time frame: 1 year
OS
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
FAPI-PET/CT response rate
Time frame: At the end of Cycle 2(each cycle is 21 days)
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 4 Feb 2026.
- Individual participant dataSharing planned: No. Privacy
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Neoadjuvant Chemoimmunotherapy or Concurrent Chemoradiotherapy in people with Resectable Esophageal Cancer, run by Ji Yongling 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 13 inclusion and 12 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 4 Feb 2026. 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 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 Kaiyi Tao, M.D (13867112921, taoky@zjcc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pCR (time frame: up to 12 weeks). 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?
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 4 Feb 2026.