Cervical CarcinomaPhase 1TIL-CxNCT04443296
Study of Tumor Infiltrating Lymphocytes Following CCRT in the Treatment of Patients With Cervical Carcinoma
A Phase 1 study testing CCRT+TIL in people with Cervical Carcinoma, run by Sun Yat-sen University at 1 site in China.
Trial summary
A Phase I trial to evaluate the feasibility, toxicity and effectiveness of cisplatin concurrent chemoradiotherapy plus TIL in treating patients with FIGO stage IIIA to IVA cervical carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Cervical Carcinoma
- What is being tested?
- CCRT+TIL
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 12 Oct 2019to 31 Dec 2022
- Phase
- Phase 1
- 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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with histologically proven squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma of the cervical uteri
- Patients with stage IIIA-IVA cervical cancer according to the International Federation of Gynecology and Obstetrics (FIGO)
- Patients who were ≥ 18 and ≤ 70 years old
- Patients with an ECOG performance status of 0, 1, or 2
- Adequate hematological, renal, and hepatic functions defined as:
- granulocytes ≥ 1.5 x 109/L, platelets ≥ 100 x 109/L, total bilirubin, ALT and AST ≤ 1.5 x upper normal limit, creatinine ≤ upper normal limit
- Patients provided written, voluntary informed consent
- Patients who were accessible to follow up and management in the treatment center
Who cannot join
- Patients with past or current history of malignancy other than the entry diagnosis except for a "cured" malignancy more than five years prior to enrollment
- Patients who received previous chemotherapy or radiotherapy
- Patients with active angina or documented myocardial infarction within the 6 months preceding registration and patients with a history of significant ventricular arrhythmia requiring medication or congestive heart failure, as well as a history of 2nd or 3rd degree heart blocks
- Patients with an active infection or other serious underlying medical conditions that would impair the ability of the patient to receive the planned treatment, including prior allergic reactions to drugs containing platinum
- Patients with dementia or altered mental status that would prohibit the understanding and providing of informed consent
- Patients with inadequate caloric and/or fluid intake
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Tumor Infiltrating Lymphocytes Following Concurrent Chemoradiotherapy in the Treatment of Patients With Cervical Carcinoma
A Phase I trial to evaluate the feasibility, toxicity and effectiveness of cisplatin concurrent chemoradiotherapy plus TIL in treating patients with FIGO stage IIIA to IVA cervical carcinoma.
Read the detailed description
Concurrent chemoradiotherapy (CCRT) was the standard treatment for locoregionally advanced cervical cancer, while the incidence of treatment failure is still high. Adjuvant chemotherapy or inducing chemotherapy addition to CCRT did not significantly improve patient survival compared to CCRT alone. Hence, there is a need for novel therapies to improve survival for these patients.
Accumulating evidence shows that tumor-infiltrating lymphocytes (TILs) selected for tumor recognition and greatly expanded in vitro are effective for treating cervical cancer patients.
This is a phase I trial to evaluate the feasibility, toxicity and effectiveness of cisplatin concurrent chemoradiotherapy plus TIL in treating patients with FIGO stage IIIA to IVA cervical carcinoma.
- Conditions
- Cervical Carcinoma
- Being tested
- CCRT+TIL
- Keywords
- Tumor Infiltrating Lymphocytes, Concurrent chemotherapy
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CCRT+TILDrug
Cisplatin based chemotherapy concurrently with radiotherapy, then TIL infusing following concurrent chemoradiotherapy
| Study group | Role | What they receive |
|---|---|---|
| CCRT+TIL | Experimental | Cisplatin based concurrent chemoradiotherapy(CCRT) combined with tumor-infiltrating lymphocyte (TIL) Receives: Drug: CCRT+TIL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Toxicity Evaluation
Patients will be monitored for clinical toxicity by by the National Cancer Institute Common Terminology Criteria for Adverse Events.
Measured: From chemo-radiotherapy start until Day30 after TIL infusion
Feasibility of CCRT in combination with TIL successful infusion
Number of patients receiving a complete TIL infusion
Measured: 30 days after start of TIL-ACT infusion
Secondary outcomes (4)
Objective Response Rate (ORR)
Disease response evaluated after the completion of the chemoradiotherapy and TIL treatment. Achievement of complete response, partial response.
Measured: 1, 3, 6, 9, 12 months
Disease control rate (DCR)
Disease response evaluated after the completion of the chemoradiotherapy and TIL treatment. Achievement of complete response, partial response or stable disease.
Measured: 1, 3, 6, 9, 12 months
Disease control time (DCT)
Duration from complete response, partial response or stable disease to progression.
Measured: 1, 3, 6, 9, 12 months
Immunological correlates to tumor response
Post-hoc exploratory analyses for immunological correlates to tumor response.
Measured: 1, 3, 6, 9, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2020
- Study start12 Oct 2019
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2022 (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 Cervical CarcinomaStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jihong Liu, Sun Yat-sen University
- Investigators
- Jihong Liu, MD, Study director, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04443296
- Sponsor's protocol ID
- SYSGO008
- Acronym
- TIL-Cx
- Status last verified
- Nov 2021
- First submitted
- 20 Jun 2020
- Last updated
- 16 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Huang H, Nie CP, Liu XF, Song B, Yue JH, Xu JX, He J, Li K, Feng YL, Wan T, Zheng M, Zhang YN, Ye WJ, Li JD, Li YF, Li JY, Cao XP, Liu ZM, Zhang XS, Liu Q, Zhang X, Liu JH, Li J. Phase I study of adjuvant immunotherapy with autologous tumor-infiltrating lymphocytes in locally advanced cervical cancer. J Clin Invest. 2022 Aug 1;132(15):e157726. doi: 10.1172/JCI157726.
PubMed 35727633
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Tumor Infiltrating Lymphocytes Following Concurrent Chemoradiotherapy in the Treatment of Patients With Cervical Carcinoma
- ClinicalTrials.gov ID
- NCT04443296
- Acronym / sponsor ID
- TIL-Cx / SYSGO008
- Conditions
- Cervical Carcinoma
- Keywords
- Tumor Infiltrating Lymphocytes, Concurrent chemotherapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 12 Oct 2019 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 23 Jun 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 Phase I trial to evaluate the feasibility, toxicity and effectiveness of cisplatin concurrent chemoradiotherapy plus TIL in treating patients with FIGO stage IIIA to IVA cervical carcinoma.
Detailed description
Concurrent chemoradiotherapy (CCRT) was the standard treatment for locoregionally advanced cervical cancer, while the incidence of treatment failure is still high. Adjuvant chemotherapy or inducing chemotherapy addition to CCRT did not significantly improve patient survival compared to CCRT alone. Hence, there is a need for novel therapies to improve survival for these patients.
Accumulating evidence shows that tumor-infiltrating lymphocytes (TILs) selected for tumor recognition and greatly expanded in vitro are effective for treating cervical cancer patients.
This is a phase I trial to evaluate the feasibility, toxicity and effectiveness of cisplatin concurrent chemoradiotherapy plus TIL in treating patients with FIGO stage IIIA to IVA cervical carcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CCRT+TIL | Experimental | Drug: CCRT+TILCisplatin based concurrent chemoradiotherapy(CCRT) combined with tumor-infiltrating lymphocyte (TIL) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients with histologically proven squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma of the cervical uteri
- Patients with stage IIIA-IVA cervical cancer according to the International Federation of Gynecology and Obstetrics (FIGO)
- Patients who were ≥ 18 and ≤ 70 years old
- Patients with an ECOG performance status of 0, 1, or 2
- Adequate hematological, renal, and hepatic functions defined as:
Key exclusion criteria (6 listed)
- Patients with past or current history of malignancy other than the entry diagnosis except for a "cured" malignancy more than five years prior to enrollment
- Patients who received previous chemotherapy or radiotherapy
- Patients with active angina or documented myocardial infarction within the 6 months preceding registration and patients with a history of significant ventricular arrhythmia requiring medication or congestive heart failure, as well as a history of 2nd or 3rd degree heart blocks
- Patients with an active infection or other serious underlying medical conditions that would impair the ability of the patient to receive the planned treatment, including prior allergic reactions to drugs containing platinum
- Patients with dementia or altered mental status that would prohibit the understanding and providing of informed consent
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 |
|---|---|---|
| CCRT+TILCisplatin based chemotherapy concurrently with radiotherapy, then TIL infusing following concurrent chemoradiotherapy | Drug | CCRT+TIL |
Primary outcome
Toxicity Evaluation
Time frame: From chemo-radiotherapy start until Day30 after TIL infusion
Patients will be monitored for clinical toxicity by by the National Cancer Institute Common Terminology Criteria for Adverse Events.
Feasibility of CCRT in combination with TIL successful infusion
Time frame: 30 days after start of TIL-ACT infusion
Number of patients receiving a complete TIL infusion
4 secondary outcomes
Objective Response Rate (ORR)
Time frame: 1, 3, 6, 9, 12 months
Disease control rate (DCR)
Time frame: 1, 3, 6, 9, 12 months
Disease control time (DCT)
Time frame: 1, 3, 6, 9, 12 months
Immunological correlates to tumor response
Time frame: 1, 3, 6, 9, 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2021.
- Derived from this study: PubMed 35727633Huang H, Nie CP, Liu XF, Song B, Yue JH, Xu JX, He J, Li K, Feng YL, Wan T, Zheng M, Zhang YN, Ye WJ, Li JD, Li YF, Li JY, Cao XP, Liu ZM, Zhang XS, Liu Q, Zhang X, Liu JH, Li J. Phase I study of adjuvant immunotherapy with autologous tumor-infiltrating lymphocytes in locally advanced cervical cancer. J Clin Invest. 2022 Aug 1;132(15):e157726. doi: 10.1172/JCI157726.
- 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. This study is not recruiting at the moment.
Jihong Liu, MD study director
Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CCRT+TIL in people with Cervical Carcinoma, run by Sun Yat-sen 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 8 inclusion and 6 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 16 Nov 2021. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Toxicity Evaluation (time frame: From chemo-radiotherapy start until Day30 after TIL infusion). 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 NCT04443296, 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 16 Nov 2021.