PARP Inhibitor for Esophageal Squamous Cell CarcinomaPhase 2NCT06055166
A Clinical Study of Chemoradiotherapy Sequential Fluzoparib in Pan-solid Tumors
A Phase 2 study testing Fluzoparib monotherapy or Fluzoparib with Camrelizumab(Only non-small cell lung cancer arm) ,or Fluzoparib combined with capecitabine (only rectal cancer arm)) in people with PARP Inhibitor for Esophageal Squamous Cell Carcinoma, run by Chongqing University Cancer Hospital.
Trial summary
This study is a prospective, multi-cohort, single-centre, phase II clinical trial designed to initially explore the efficacy and safety of sequential fluzoparib with chemoradiotherapy in pan-solid tumours. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- PARP Inhibitor for Esophageal Squamous Cell Carcinoma
- What is being tested?
- Fluzoparib monotherapy or Fluzoparib with Camrelizumab(Only non-small cell lung cancer arm) ,or Fluzoparib combined with capecitabine (only rectal cancer arm))
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2023to 31 May 2026
- Phase
- Phase 2
- 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
- -
- Subjects must meet all of the following criteria to be enrolled in this study:
- subjects voluntarily enrolled in this study, signed informed consent, good compliance, and co-operated with follow-up visits;
- age 18-75 years (calculated on the date of signing the informed consent);
- histologically or cytologically confirmed solid tumours as follows: Cohort A: patients with resectable locally advanced rectal adenocarcinoma not previously treated for rectal cancer (clinical stage T3-4 or N+ as assessed by MRI, according to AJCC 8th edition staging), with the lower edge of the tumour ≤ 10 cm away from the anal verge, with R0 resection predicted and planned for surgery after neoadjuvant therapy, and with no contraindications to surgery; Cohort B: patients with locally advanced, unresectable NSCLC with histologically or cytologically confirmed diagnosis who have not previously received treatment for lung cancer (IIIA, IIIB, IIIC, according to the International Manual of Thoracic Oncology Lung Cancer Staging Studies 8th edition staging); Cohort C: patients with locally advanced, unresectable or contraindicated for or refusing surgery for squamous oesophageal cancer with histological or cytological confirmation who had not received previous treatment for oesophageal cancer (clinical staging T1b-4bN0M0/T1-4bN+M0, according to AJCC 8th edition staging); Cohort D: Cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the cervix that has not received prior treatment for cervical cancer (excluding surgical pathological staging) and that has been confirmed by pathohistology. Clinical staging or imaging staging or surgical pathological staging of locally advanced cervical cancer (2018 FIGO staging of IB3, Stage IIA2-IVA patients);
- NSCLC without sensitive EGFR, ALK or ROS1 gene mutations confirmed by histological or cytological specimens;
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- ECOG PS score: 0 to 1;
- subjects with normal swallowing function;
- normal major organ function, including:
- Routine blood tests (no transfusion of blood or blood products, no correction with G-CSF and other haematopoietic stimulating factors within 14 days prior to the first treatment): i. Neutrophil count ≥ 1.5 × 109/L ii. Platelet count ≥ 100×109/L iii. Haemoglobin ≥ 90 g/L. b) Blood biochemistry: i. Total bilirubin ≤ 1.5×ULN ii. ALT ≤ 2.5×ULN, AST ≤ 2.5×ULN. iii. iii. serum creatinine ≤ 1.5 × ULN, or creatinine clearance ≥ 50 mL/min c) Coagulation function: i. International Normalised Ratio (INR) ≤ 1.5 x ULN ii. Activated partial thromboplastin time (APTT) ≤ 1.5 x ULN
- Female subjects of childbearing potential are required to have a negative serum pregnancy test within 72 hours prior to the first dose and are not breastfeeding and are using effective contraception (e.g., IUD, birth control pills, or condoms) for the duration of the trial, and for 6 months after the last administration of fluzoparib/chemotherapy, or 2 months after the last administration of karelizumab, whichever is longer; for male subjects whose partner is a female of childbearing potential, the results of the serum pregnancy test must be negative and they must be not breastfeeding. male subjects whose partner is a female of childbearing potential should be surgically sterilised or agree to use effective contraception for the duration of the trial and for 6 months after the last administration of fluzoparib/chemotherapy or 2 months after the last administration of carrelizumab, whichever is longer, and sperm donation is not permitted during the study.
- patients judged by the investigator to be acceptable for the study intervention programme.
Who cannot join
- Subjects with any of the following traits or conditions will not be allowed to enter this study:
- patients with a previous history of perforation, fistula, bleeding or airway stenosis;
- a history of allergy or risk of allergy to the study intervention protocol;
- subjects may receive other systemic anti-tumour therapy during the study period;
- the presence of abnormal gastrointestinal function which, in the judgement of the investigator, may interfere with drug absorption
- the presence of uncontrollable pleural effusion, pericardial effusion, or ascites that requires repeated drainage;
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- subjects with congenital or acquired immune deficiency (e.g., HIV-infected), or active hepatitis (Hepatitis B reference: HBsAg positive, HBV DNA ≥2000 IU/ml; Hepatitis C reference: HCV antibody positive, HCV viral copy number > upper limit of normal);
- have clinical symptoms or diseases of the heart that are not well controlled, such as: (1) NYHA class 2 or higher heart failure (2) unstable angina pectoris (3) myocardial infarction within 1 year (4) clinically significant supraventricular or ventricular arrhythmia that requires treatment or intervention (5) those with a QTc > 470 ms;
- those with abnormal coagulation (INR > 1.5 or prothrombin time (PT) > ULN + 4 seconds), bleeding tendency or who are receiving thrombolytic or anticoagulant therapy are permitted to receive low-dose low molecular heparin or oral aspirin for prophylactic anticoagulation during the trial;
- have had a serious infection (CTCAE > grade 2) within 4 weeks prior to first use of study drug, such as severe pneumonia requiring hospitalisation, bacteraemia, or infectious co-morbidities; except for prophylactic antibiotic use in those who have baseline chest imaging suggestive of active lung inflammation, signs and symptoms of infection within 14 days prior to the first use of study drug, or who require treatment with oral or intravenous antibiotics ;
- patients with any active autoimmune disease or a history of autoimmune disease with potential for relapse [including, but not limited to, autoimmune hepatitis, interstitial pneumonitis, uveitis, enterocolitis, pituitary gland inflammation, vasculitis, nephritis, hyperthyroidism, and hypothyroidism (patients who can be controlled by hormone replacement therapy alone may be enrolled)] are not eligible for enrollment into Cohort B; patients with skin diseases that do not require systemic therapy Patients with skin diseases that do not require systemic treatment, such as leukoplakia, psoriasis, alopecia areata, patients with type I diabetes mellitus controlled by insulin therapy or patients with a history of asthma that has completely resolved in childhood and does not require any intervention can be enrolled; patients with asthma requiring bronchodilator intervention cannot be enrolled in Cohort B;
- women who are pregnant or breastfeeding;
- the presence of other factors that, in the judgement of the investigator, could lead to forced termination of the study midway, such as the presence of other serious illnesses (including psychiatric illnesses) that require comorbid treatment, alcoholism, drug abuse, family or social factors that may affect the safety of or compliance with the subject;
About this study
Official title: A Prospective, Multi-cohort, Single-center Phase II Clinical Study of Chemoradiotherapy Sequential Fluzoparib in Pan-solid Tumors
This study is a prospective, multi-cohort, single-centre, phase II clinical trial designed to initially explore the efficacy and safety of sequential fluzoparib with chemoradiotherapy in pan-solid tumours. The study is designed for patients with untreated surgically resectable rectal cancer and untreated locally advanced unresectable non-small cell lung cancer, oesophageal squamous cancer, and cervical cancer.
- Being tested
- Fluzoparib monotherapy or Fluzoparib with Camrelizumab(Only non-small cell lung cancer arm) ,or Fluzoparib combined with capecitabine (only rectal cancer arm))
- Keywords
- Esophageal squamous cell carcinoma
- 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.
Fluzoparib monotherapy or Fluzoparib with Camrelizumab(Only non-small cell lung cancer arm) ,or Fluzoparib combined with capecitabine (only rectal cancer arm))Drug
Arm A: untreated surgically resectable rectal cancer. Patients accept preoperative long-range synchronous chemoradiotherapy → fluzoparib combined with capecitabine (Q3W, 4 treatment cycles) → surgery → observation and follow-up Arm B, C and D: include untreated locally advanced unresectable non-small cell lung cancer, esophageal squamous cell carcinoma and cervical carcinoma. Patients accept radical synchronous chemoradiotherapy following → fluzoparib combined with camrelizumab or fluzoparib monotherapy maintenance treatment for 17 cycles
| Study group | Role | What they receive |
|---|---|---|
| untreated surgically resectable rectal cancer | Experimental | Not described Receives: Drug: Fluzoparib monotherapy or Fluzoparib with Camrelizumab(Only non-small cell lung cancer arm) ,or Fluzoparib combined with capecitabine (only rectal cancer arm)) |
| untreated locally advanced unresectable non-small cell lung cancer | Experimental | Not described Receives: Drug: Fluzoparib monotherapy or Fluzoparib with Camrelizumab(Only non-small cell lung cancer arm) ,or Fluzoparib combined with capecitabine (only rectal cancer arm)) |
| untreated locally advanced unresectable esophageal squamous cell carcinoma | Experimental | Not described Receives: Drug: Fluzoparib monotherapy or Fluzoparib with Camrelizumab(Only non-small cell lung cancer arm) ,or Fluzoparib combined with capecitabine (only rectal cancer arm)) |
| untreated locally advanced unresectable cervical carcinoma | Experimental | Not described Receives: Drug: Fluzoparib monotherapy or Fluzoparib with Camrelizumab(Only non-small cell lung cancer arm) ,or Fluzoparib combined with capecitabine (only rectal cancer arm)) |
What is being measured
The primary outcome is the main question the study is designed to answer.
pCR
Pathological Complete Response
Measured: within 14 working days after operation
PFS rate
12-month Progression-Free Survival Rate
Measured: from initially chemoradiotherapy follow up 12 months
Secondary outcomes (6)
MPR
Main Pathological Remission
Measured: within 14 working days after operation
R0 resection rate
R0 resection rate
Measured: within 14 working days after operation
PFS
Progression-Free-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
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
ORR
Objective Response Rate
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
AEs
adverse events
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2023
- Study start1 Nov 2023 (estimated)
- Primary completion30 Nov 2024 (estimated)
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PARP Inhibitor for Esophageal Squamous Cell CarcinomaStudies 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
- Non-randomised
- Intervention model
- Sequential
- Model description
- 4 arms include rectal cancer, non-small cell lung cancer, oesophageal squamous cancer, and cervical cancer, accept sequential fluzoparib after chemoradiotherapy
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chongqing University Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06055166
- Sponsor's protocol ID
- ChongqingCancer CZLS2023154-A
- Status last verified
- Jul 2023
- First submitted
- 26 Jul 2023
- Last updated
- 26 Sep 2023
- Results posted
- No
- Data monitoring committee
- 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 26 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-cohort, Single-center Phase II Clinical Study of Chemoradiotherapy Sequential Fluzoparib in Pan-solid Tumors
- ClinicalTrials.gov ID
- NCT06055166
- Acronym / sponsor ID
- ChongqingCancer CZLS2023154-A
- Keywords
- Esophageal squamous cell carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Chongqing University Cancer HospitalUniversity, hospital or other
- Study start
- 1 Nov 2023 (estimated)
- Primary completion
- 30 Nov 2024 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 26 Sep 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.
This study is a prospective, multi-cohort, single-centre, phase II clinical trial designed to initially explore the efficacy and safety of sequential fluzoparib with chemoradiotherapy in pan-solid tumours. The study is designed for patients with untreated surgically resectable rectal cancer and untreated locally advanced unresectable non-small cell lung cancer, oesophageal squamous cancer, and cervical cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- 4 arms include rectal cancer, non-small cell lung cancer, oesophageal squamous cancer, and cervical cancer, accept sequential fluzoparib after chemoradiotherapy
| Arm | Type | Receives |
|---|---|---|
| untreated surgically resectable rectal cancer | Experimental | Drug: Fluzoparib monotherapy or Fluzoparib with Camrelizumab(Only non-small cell lung cancer arm) ,or Fluzoparib combined with capecitabine (only rectal cancer arm)) |
| untreated locally advanced unresectable non-small cell lung cancer | Experimental | Drug: Fluzoparib monotherapy or Fluzoparib with Camrelizumab(Only non-small cell lung cancer arm) ,or Fluzoparib combined with capecitabine (only rectal cancer arm)) |
| untreated locally advanced unresectable esophageal squamous cell carcinoma | Experimental | Drug: Fluzoparib monotherapy or Fluzoparib with Camrelizumab(Only non-small cell lung cancer arm) ,or Fluzoparib combined with capecitabine (only rectal cancer arm)) |
| untreated locally advanced unresectable cervical carcinoma | Experimental | Drug: Fluzoparib monotherapy or Fluzoparib with Camrelizumab(Only non-small cell lung cancer arm) ,or Fluzoparib combined with capecitabine (only rectal cancer arm)) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- -
- subjects voluntarily enrolled in this study, signed informed consent, good compliance, and co-operated with follow-up visits;
- age 18-75 years (calculated on the date of signing the informed consent);
- histologically or cytologically confirmed solid tumours as follows: Cohort A: patients with resectable locally advanced rectal adenocarcinoma not previously treated for rectal cancer (clinical stage T3-4 or N+ as assessed by MRI, according to AJCC 8th edition staging), with the lower edge of the tumour ≤ 10 cm away from the anal verge, with R0 resection predicted and planned for surgery after neoadjuvant therapy, and with no contraindications to surgery; Cohort B: patients with locally advanced, unresectable NSCLC with histologically or cytologically confirmed diagnosis who have not previously received treatment for lung cancer (IIIA, IIIB, IIIC, according to the International Manual of Thoracic Oncology Lung Cancer Staging Studies 8th edition staging); Cohort C: patients with locally advanced, unresectable or contraindicated for or refusing surgery for squamous oesophageal cancer with histological or cytological confirmation who had not received previous treatment for oesophageal cancer (clinical staging T1b-4bN0M0/T1-4bN+M0, according to AJCC 8th edition staging); Cohort D: Cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the cervix that has not received prior treatment for cervical cancer (excluding surgical pathological staging) and that has been confirmed by pathohistology. Clinical staging or imaging staging or surgical pathological staging of locally advanced cervical cancer (2018 FIGO staging of IB3, Stage IIA2-IVA patients);
- NSCLC without sensitive EGFR, ALK or ROS1 gene mutations confirmed by histological or cytological specimens;
Key exclusion criteria (13 listed)
- Subjects with any of the following traits or conditions will not be allowed to enter this study:
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 |
|---|---|---|
| Fluzoparib monotherapy or Fluzoparib with Camrelizumab(Only non-small cell lung cancer arm) ,or Fluzoparib combined with capecitabine (only rectal cancer arm))Arm A: untreated surgically resectable rectal cancer. Patients accept preoperative long-range synchronous chemoradiotherapy → fluzoparib combined with capecitabine (Q3W, 4 treatment cycles) → surgery → observation and follow-up Arm B, C and D: include untreated locally advanced unresectable non-small cell lung cancer, esophageal squamous cell carcinoma and cervical carcinoma. Patients accept radical synchronous chemoradiotherapy following → fluzoparib combined with camrelizumab or fluzoparib monotherapy maintenance treatment for 17 cycles | Drug | untreated locally advanced unresectable cervical carcinoma, untreated locally advanced unresectable esophageal squamous cell carcinoma, untreated locally advanced unresectable non-small cell lung cancer, untreated surgically resectable rectal cancer |
Primary outcome
pCR
Time frame: within 14 working days after operation
Pathological Complete Response
PFS rate
Time frame: from initially chemoradiotherapy follow up 12 months
12-month Progression-Free Survival Rate
6 secondary outcomes
MPR
Time frame: within 14 working days after operation
R0 resection rate
Time frame: within 14 working days after operation
PFS
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
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
ORR
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
AEs
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2023.
- Individual participant dataSharing planned: No
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.
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 Fluzoparib monotherapy or Fluzoparib with Camrelizumab(Only non-small cell lung cancer arm) ,or Fluzoparib combined with capecitabine (only rectal cancer arm)) in people with PARP Inhibitor for Esophageal Squamous Cell Carcinoma, run by Chongqing University Cancer 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 12 inclusion and 13 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 26 Sep 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?
Results are not available in the source record.
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?
pCR (time frame: within 14 working days after operation). 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 26 Sep 2023; AzTrials last refreshed its copy on 6 Nov 2026.