Advanced Esophageal Squamous Carcinoma With OligometastasesPhase 2NCT06143722
Synchronous or Sequential Radiotherapy for Advanced Esophageal Squamous Cell Carcinoma With Oligometastases.
A Phase 2 study testing simultaneous with radiotherapy and synchronous with radiotherapy in people with Advanced Esophageal Squamous Carcinoma With Oligometastases, run by West China Hospital.
Trial summary
A randomized, prospective phase II trial was conducted to explore the timing of radiotherapy intervention in combination with chemotherapy and immunotherap in order to provide an effective treatment for patients with advanced esophageal squamous carcinoma with oligometastases. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Esophageal Squamous Carcinoma With Oligometastases
- What is being tested?
- simultaneous with radiotherapy and synchronous with radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- No sites listed yet
- Study dates
- 30 Nov 2023to 30 Nov 2026
- 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
- Aged 18-75 years old, male or female;
- Patients with pathologically diagnosed esophageal squamous cell carcinoma;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1, and <10% weight loss within six months;
- Patients with distant organ metastasis or nonregional lymph node metastasis, or distant organ/nonregional lymph node metastasis with regional lymph node metastasis, as defined by the AJCC 8th edition;
- All positive regional lymph nodes were counted as one lesion, and adjacent metastatic nonregional lymph nodes could be treated as one lesion;
- All metastases must be amenable to local radiotherapy;
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- 5 or fewer metastatic lesions including tumor beds and recurrent anastomoses, ≤ 4 metastatic lesions in any organ system, and a maximum lesion diameter ≤ 5 cm;
- not including fading lesions during prior therapy (i.e., no longer visible on CT or metabolically active eliminated on PET-CT);
- All metastases have not received local treatment such as radiotherapy, surgery, radiofrequency ablation prior to enrollment (Lesions located in the area of prior radiotherapy may be considered target lesions if progression is confirmed and considered measurable according to RECIST 1.1);
- Measurable lesions ≥1 cm (maximum diameter) determined by CT or MRI, or ≥2 cm by other radiologic techniques, according to RECIST criteria;
- Expected survival time of at least 12 weeks;
- No previous surgery, chemotherapy, radiation therapy or immunotherapy for any cancer within the past 6 months;
- Laboratory test indicators meet the following criteria:
- ①Bone marrow function: hemoglobin (Hb) ≥80g/L; white blood cell count (WBC) ≥lower limit of normal; absolute neutrophil count (ANC) ≥1.5×10^9 /L; platelet count ≥80×109 /L;
- ②Renal function: Cr ≤ ULN (upper limit of normal) × 1.5, endogenous creatinine clearance (Ccr) ≥ 45 ml/min;
- ③Liver function: total bilirubin ≤ ULN × 1.5; ALT and AST ≤ ULN × 2.5; (if there is liver metastasis, total bilirubin is not higher than 3 times the upper limit of normal, and transaminases are not higher than 5 times the upper limit of normal);
- ④Coagulation function: international normalized ratio of prothrombin time ≤ ULN × 1.5, and partial thromboplastin time within the normal value;
- Females of child-bearing potential agree to use contraception during the study period and for 6 months after the completion of the study; patients who have had a negative serum or urine pregnancy test within seven days prior to enrollment in the study and who are not breastfeeding; and males agreeing to use contraception during the study period and for 6 months after the completion of the study;
- Subjects who can understand the study situation and voluntarily sign the informed consent form;
- Patients are expected to be compliant and able to follow up on efficacy and adverse events according to protocol requirements.
Who cannot join
- Metastases with faint borders making radiotherapy treatment infeasible; metastases located within 3 cm of previously irradiated structures;
- Poor nutritional status with a BMI < 18.5 Kg/m^2, if symptomatic nutritional support was corrected prior to randomization to group, enrollment may be considered after evaluation by the principal investigator;
- Severe impairment of lung function.
- patients with an esophageal mediastinal fistula and/or esophagotracheal fistula prior to treatment or at risk of invasion of vital vessels with lethal bleeding;
- Diagnosis of other malignant tumors (except carcinoma in situ, basal cell carcinoma, etc.) within the previous 5 years;
- Presence of any active autoimmune disease or history of autoimmune disease; immunodeficiency, active tuberculosis, hepatitis B ( hepatitis B virus titer HBV-DNA <500 IU/ml after treatment and if liver function is normal will be allowed), or positive test for hepatitis C virus.
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- Presence of hereditary or acquired bleeding and thrombotic tendencies;
- Treatment with immunosuppressive drugs or corticosteroids (> 10 mg prednisone or equivalent per day) within 14 days prior to enrollment; patients are allowed to receive steroid therapy to control CNS-related symptoms, but the dose must ≤ 5 mg per day of dexamethasone (or equivalent); in the absence of an active autoimmune disease, inhaled or topical steroids and adrenal gland replacement dosing are acceptable; alternative therapies (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) are permitted; patients with experimental medications that require premedication with corticosteroids are not restricted;
- Allergic reaction to any of the study drugs or contraindication to radiotherapy;
- Participation in another clinical trial within 30 days prior to enrollment;
- Individuals considered by the investigator to be unsuitable for enrollment.
About this study
Official title: Camrelizumab Plus Chemotherapy in Combination With Synchronous or Sequential Radiotherapy for Advanced Esophageal Squamous Cell Carcinoma With Oligometastases: a Randomized Controlled Phase II Clinical Study
A randomized, prospective phase II trial was conducted to explore the timing of radiotherapy intervention in combination with chemotherapy and immunotherap in order to provide an effective treatment for patients with advanced esophageal squamous carcinoma with oligometastases.
- Being tested
- simultaneous with radiotherapy, synchronous with radiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
simultaneous with radiotherapyRadiation
Chemotherapy combined with immunotherapy simultaneous with radiotherapy
synchronous with radiotherapyRadiation
Chemotherapy combined with immunotherapy synchronous with radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| Simultaneous radiotherapy group | Experimental | Not described Receives: Radiation: simultaneous with radiotherapy |
| Sequential radiotherapy group | Active comparator | Not described Receives: Radiation: synchronous with radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS)
Progression-free survival will be measured as time to either progression or death.
Measured: 12 months
Secondary outcomes (4)
Overall survival (OS)
Overall survival will be measured as time to death from any cause.
Measured: 12 months
Disease Control Rate (DCR)
The DCR was defined as the proportion of patients with the best efficacy (complete response or partial response or stable disease).
Measured: 12 months
Objective response rate (ORR)
Defined as the response to treatment as assessed by the investigator based on the Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST 1.1) criteria, containing cases of complete response, and partial response.
Measured: 12 months
Adverse events
toxicity values caused by treatment.
Measured: 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2023
- Study start30 Nov 2023 (estimated)
- Primary completion30 Nov 2025 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Esophageal Squamous Carcinoma With OligometastasesStudies of the same condition, open and under way.
- More trials run by West China HospitalThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized, prospective phase II trial.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 63 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ting Liu, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06143722
- Sponsor's protocol ID
- WestChinaHS
- Status last verified
- Nov 2023
- First submitted
- 16 Nov 2023
- Last updated
- 22 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Camrelizumab Plus Chemotherapy in Combination With Synchronous or Sequential Radiotherapy for Advanced Esophageal Squamous Cell Carcinoma With Oligometastases: a Randomized Controlled Phase II Clinical Study
- ClinicalTrials.gov ID
- NCT06143722
- Acronym / sponsor ID
- WestChinaHS
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 63 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 30 Nov 2023 (estimated)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 22 Nov 2023 (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 randomized, prospective phase II trial was conducted to explore the timing of radiotherapy intervention in combination with chemotherapy and immunotherap in order to provide an effective treatment for patients with advanced esophageal squamous carcinoma with oligometastases.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A randomized, prospective phase II trial.
| Arm | Type | Receives |
|---|---|---|
| Simultaneous radiotherapy group | Experimental | Radiation: simultaneous with radiotherapy |
| Sequential radiotherapy group | Active comparator | Radiation: synchronous with radiotherapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Aged 18-75 years old, male or female;
- Patients with pathologically diagnosed esophageal squamous cell carcinoma;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1, and <10% weight loss within six months;
- Patients with distant organ metastasis or nonregional lymph node metastasis, or distant organ/nonregional lymph node metastasis with regional lymph node metastasis, as defined by the AJCC 8th edition;
- All positive regional lymph nodes were counted as one lesion, and adjacent metastatic nonregional lymph nodes could be treated as one lesion;
Key exclusion criteria (11 listed)
- Metastases with faint borders making radiotherapy treatment infeasible; metastases located within 3 cm of previously irradiated structures;
- Poor nutritional status with a BMI < 18.5 Kg/m^2, if symptomatic nutritional support was corrected prior to randomization to group, enrollment may be considered after evaluation by the principal investigator;
- Severe impairment of lung function.
- patients with an esophageal mediastinal fistula and/or esophagotracheal fistula prior to treatment or at risk of invasion of vital vessels with lethal bleeding;
- Diagnosis of other malignant tumors (except carcinoma in situ, basal cell carcinoma, etc.) within the previous 5 years;
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 |
|---|---|---|
| simultaneous with radiotherapyChemotherapy combined with immunotherapy simultaneous with radiotherapy | Radiation | Simultaneous radiotherapy group |
| synchronous with radiotherapyChemotherapy combined with immunotherapy synchronous with radiotherapy | Radiation | Sequential radiotherapy group |
Primary outcome
Progression-Free Survival (PFS)
Time frame: 12 months
Progression-free survival will be measured as time to either progression or death.
4 secondary outcomes
Overall survival (OS)
Time frame: 12 months
Disease Control Rate (DCR)
Time frame: 12 months
Objective response rate (ORR)
Time frame: 12 months
Adverse events
Time frame: 12 months.
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 22 Nov 2023.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing simultaneous with radiotherapy and synchronous with radiotherapy in people with Advanced Esophageal Squamous Carcinoma With Oligometastases, run by West China Hospital.
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 20 inclusion and 11 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 22 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (PFS) (time frame: 12 months). 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 22 Nov 2023.