Thyroid CancerPhase 2NCT05659186
PD-1 Inhibitor and Anlotinib Combined With Multimodal Radiotherapy in Recurrent or Metastatic Anaplastic Thyroid Cancer
A Phase 2 study testing Tislelizumab, Anlotinib and Radiotherapy in people with Thyroid Cancer, run by West China Hospital at 1 site in China.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of PD-1 inhibitor and anlotinib combined with multimodal radiotherapy for the second-line treatment of recurrent or metastatic anaplastic thyroid cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid Cancer
- What is being tested?
- Tislelizumab, Anlotinib and Radiotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 30 Dec 2022to 30 Dec 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or above.
- Patients with pathologically confirmed Undifferentiated thyroid carcinoma and meet the following conditions:
- Were diagnosed with distant metastasis;
- Were intolerant to or failed first-line treatment.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
- Expected life is greater than or equal to 12 weeks.
Show all 13Show fewer
- There is at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
- Adequate organ and bone marrow function:
- Absolute neutrophil count ≥ 1.5 × 10^9/L, hemoglobin ≥ 80 g/L, platelets ≥ 80 × 10^9/L;
- ALT, AST and ALP < 2.5× upper limit of normal (ULN), total bilirubin ≤ 2×ULN; albumin≥ 2.8 g/dL；
- Creatinine clearance ≥ 60 ml/min;
- INR≤ 1.5, APTT≤ 1.5×ULN.
- Written informed consent.
Who cannot join
- Existing tumor-related hemorrhage。
- History of other malignancies (except for the history of malignant tumors that have been cured and have not recurred within 5 years, such as skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, in situ cervical cancer, and gastrointestinal mucosal cancer, etc.）
- Have an active autoimmune disease requiring systemic treatment or a documented history of clinically severe autoimmune disease.
- Any history of allergic disease, severe hypersensitivity reaction to drugs, or allergy to the study drug components.
- Any prior therapy with:
- Toxicity from prior antitumor therapy has not recovered to ≤ CTCAE Version 5.0 Grade 1 or the level specified by the inclusion/exclusion criteria.
Show all 19Show fewer
- Antitumor vaccine;
- Any active vaccine against infectious disease within 4 weeks prior to the first dose or planned during the study period;
- Major surgery or serious trauma within 4 weeks before the first dose;
- With serious medical diseases, such as grade II and above cardiac dysfunction (NYHA criteria), ischemic heart disease, supraventricular or ventricular arrhythmia, poorly controlled diabetes mellitus, poorly controlled hypertension, echocardiographic ejection fraction < 50%, etc.
- With interstitial pneumonitis, non-infectious pneumonitis, active pulmonary tuberculosis, or a history of pulmonary tuberculosis infection that was not controlled by treatment.
- With hyperthyroidism, or organic thyroid disease.
- With active infection, or unexplained fever during the screening period or 48 hours before the first dose.
- With active hepatitis B or C, or known history of positive HIV test, or acquired immunodeficiency syndrome.
- History of a clear neurological or psychiatric disorder.
- History of drug abuse or alcohol abuse.
- Women who are pregnant or breastfeeding, or have a reproductive plan from the screening period to 3 months after the end of the study, or have sex without contraceptive measures, or are unwilling to take appropriate contraceptive measures.
- Received any investigational drug within 4 weeks prior to the first dose, or concurrently enrolled in another clinical trial.
- Any other factors that are not suitable for inclusion in this study judged by investigators.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xingchen Peng
Chengdu, Sichuan, 610041
Xingchen Peng, +86 18980606753, pxx2014@scu.edu.cn
About this study
Official title: A Phase II Study of the Efficacy and Safety of PD-1 Inhibitor and Anlotinib Combined With Multimodal Radiotherapy in the Second-line Treatment of Recurrent or Metastatic Anaplastic Thyroid Cancer
The purpose of this study is to evaluate the efficacy and safety of PD-1 inhibitor and anlotinib combined with multimodal radiotherapy for the second-line treatment of recurrent or metastatic anaplastic thyroid cancer.
Read the detailed description
Thyroid cancer (TC) is the most common malignant tumor of the endocrine system. It is more common in women and accounts for approximately 4% of all new malignancies in women. TC can be classified according to its pathological type: papillary carcinoma, follicular carcinoma, Hurthle cell carcinoma, medullary carcinoma, and anaplastic thyroid carcinoma (ATC). ATC is more aggressive than other types and tends to metastasize at an early stage. Although ATC accounts for only 1.6%-4% of all TC, the mortality rate is 14%-40%. According to the American Joint Committee on Cancer (AJCC) staging criteria, all ATC is considered stage IV once diagnosed, regardless of the size of the primary site or lymph node metastasis. Until now, the best treatment options for ATC have been unclear, and currently, a combination of treatment options is used. However, the efficiency of treatment is less than 15% and most patients experience recurrence and distant metastases. There is an urgent need for safe and effective treatment options for patients with ATC.
Radiotherapy, as one of the important local treatments, can reduce the tumor load and alleviate local symptoms. Several studies have demonstrated that radiotherapy can improve the prognosis of patients with ATC. The results of a meta-analysis covering 17 studies with a total of 1147 patients showed that postoperative radiotherapy improved the prognosis of patients with ATC compared to those who underwent surgery only. Meanwhile, the results of another large retrospective study showed that radiotherapy resulted in sustained local progression-free survival and overall survival in the treatment of patients with locally advanced ATC and that a radiotherapy dose of ≥60 Gy was an independent prognostic factor (p=0.01). The prognostic role of radiotherapy and different radiotherapy doses was also confirmed in another meta-analysis from the National Cancer Database (NCDB), which showed that patients with inoperable ATC may benefit from radiotherapy at higher irradiation doses (60-70 Gy vs 45-59.9 Gy). It can thus be seen that both operable and inoperable ATC patients, may benefit from radiotherapy and that the dose of radiotherapy may correlate with their survival benefit.
For the systemic treatment of patients with ATC, the NCCN guidelines recommend first-line regimens including paclitaxel combined with carboplatin, doxorubicin combined with doxorubicin, single-agent paclitaxel and single-agent doxorubicin, but patients with ATC respond poorly to treatment and there is no recommended optimal regimen for patients who develop recurrence or metastasis after first-line therapy. In recent years, PD-1/PD-L1 has been used in melanoma and a variety of other solid tumors have demonstrated promising efficacy. The results of a retrospective study in 2017 showed positive PD-1 expression in all specimens of the 16 ATC patients observed, while almost all patients (13/16) were positive for PD-L1 expression. In vitro experiments have also shown that PD-1 blockers can reinvigorate the cytotoxic effects of NK cells, thereby enhancing the killing effect on tumor cells. This lays the theoretical foundation for the use of PD-1/PD-L1 blockers in the treatment of ATC. Multi-target tyrosine kinase inhibitors have shown significant anti-tumor effects in a variety of tumor types, including thyroid cancer, by inhibiting angiogenic and proliferative signaling. Anrotinib is a small molecule multi-target complex kinase inhibitor developed in China and has been reported to be safe and effective in the treatment of patients with advanced refractory solid tumors. In addition to this, the anti-tumor activity of anrotinib in ATC has been In vivo and in vitro assays have demonstrated that anlotinib inhibits ATC cell proliferation and inhibits the migration of thyroid cancer cells in vitro and the growth of xenograft thyroid tumors in mice.
The findings suggest that there may be synergy between PD-1/PD-L1 blockers and complex kinase inhibitors and that PD-1/PD-L1 blockers may improve the tumor microenvironment in ATC, thereby increasing the efficacy of complex kinase inhibitors. This suggests that the combination of PD-1/PD-L1 blockers and complex kinase inhibitors may be an effective treatment option for ATC and that PD-1/PD-L1 blockers may improve resistance to complex kinase inhibitor therapy. PD-L1 blockers may improve the resistance that occurs with complex kinase inhibitor therapy. Meanwhile, the combination of PD-1/PD-L1 blockers with radiotherapy has been shown to have a synergistic effect in several studies. Radiotherapy combined with immunotherapy can activate specific T-cell immune responses and alter the suppressive effect of the tumor microenvironment on the immune system, resulting in durable anti-tumor activity. Combining radiotherapy with PD-1/PD-L1 blockers for the treatment of undifferentiated thyroid cancer may demonstrate better therapeutic outcomes.
- Conditions
- Thyroid Cancer
- Being tested
- Tislelizumab, Anlotinib, Radiotherapy
- Keywords
- Thyroid Cancer, Immunotherapy, Radiotherapy, Anlotinib
- Medical subject headings
- Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TislelizumabDrug
Also called BGB-A317
200mg IV Q3W
AnlotinibDrug
Also called AL3818
12mg PO QD
RadiotherapyRadiation
Multimodal Radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| Treatment Cohort | Experimental | Tislelizumab administration on day 1, and Anlotinib continuous administration from days 1 to 14， every three weeks Radiotherapy Receives: Drug: Tislelizumab; Drug: Anlotinib; Radiation: Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate
ORR is defined as the percentage of patients who achieve a response, which can either be complete response (complete disappearance of lesions) or partial response (reduction in the sum of maximal tumor diameters by at least 30% or more)
Measured: Up to 60 months
Secondary outcomes (3)
Progress-Free Survival
PFS is defined as the time from the administration of the first dose to first disease progression or death.
Measured: Up to 60 months
Overall Survival
OS is defined as the time from the administration of the first dose to death.
Measured: Up to 60 months
Adverse events
defined as the number of participants with adverse events using CTCAE Criteria.
Measured: Up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2022
- Study start30 Dec 2022 (estimated)
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Thyroid CancerStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xingchen Peng, West China Hospital
- Investigators
- Xingchen Peng, Professor, Principal investigator, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05659186
- Sponsor's protocol ID
- ChiCTR2100054455
- Status last verified
- Dec 2022
- First submitted
- 8 Dec 2022
- Last updated
- 21 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lin B, Ma H, Ma M, Zhang Z, Sun Z, Hsieh IY, Okenwa O, Guan H, Li J, Lv W. The incidence and survival analysis for anaplastic thyroid cancer: a SEER database analysis. Am J Transl Res. 2019 Sep 15;11(9):5888-5896. eCollection 2019.
PubMed 31632557Siegel RL, Miller KD, Jemal A. Cancer statistics, 2020. CA Cancer J Clin. 2020 Jan;70(1):7-30. doi: 10.3322/caac.21590. Epub 2020 Jan 8.
PubMed 31912902Haddad RI, Nasr C, Bischoff L, Busaidy NL, Byrd D, Callender G, Dickson P, Duh QY, Ehya H, Goldner W, Haymart M, Hoh C, Hunt JP, Iagaru A, Kandeel F, Kopp P, Lamonica DM, McIver B, Raeburn CD, Ridge JA, Ringel MD, Scheri RP, Shah JP, Sippel R, Smallridge RC, Sturgeon C, Wang TN, Wirth LJ, Wong RJ, Johnson-Chilla A, Hoffmann KG, Gurski LA. NCCN Guidelines Insights: Thyroid Carcinoma, Version 2.2018. J Natl Compr Canc Netw. 2018 Dec;16(12):1429-1440. doi: 10.6004/jnccn.2018.0089.
PubMed 30545990Sun C, Li Q, Hu Z, He J, Li C, Li G, Tao X, Yang A. Treatment and prognosis of anaplastic thyroid carcinoma: experience from a single institution in China. PLoS One. 2013 Nov 5;8(11):e80011. doi: 10.1371/journal.pone.0080011. eCollection 2013.
PubMed 24224029Perrier ND, Brierley JD, Tuttle RM. Differentiated and anaplastic thyroid carcinoma: Major changes in the American Joint Committee on Cancer eighth edition cancer staging manual. CA Cancer J Clin. 2018 Jan;68(1):55-63. doi: 10.3322/caac.21439. Epub 2017 Nov 1.
PubMed 29092098Subbiah V, Kreitman RJ, Wainberg ZA, Cho JY, Schellens JHM, Soria JC, Wen PY, Zielinski C, Cabanillas ME, Urbanowitz G, Mookerjee B, Wang D, Rangwala F, Keam B. Dabrafenib and Trametinib Treatment in Patients With Locally Advanced or Metastatic BRAF V600-Mutant Anaplastic Thyroid Cancer. J Clin Oncol. 2018 Jan 1;36(1):7-13. doi: 10.1200/JCO.2017.73.6785. Epub 2017 Oct 26.
PubMed 29072975Chintakuntlawar AV, Yin J, Foote RL, Kasperbauer JL, Rivera M, Asmus E, Garces NI, Janus JR, Liu M, Ma DJ, Moore EJ, Morris JC 3rd, Neben-Wittich M, Price DL, Price KA, Ryder M, Van Abel KM, Hilger C, Samb E, Bible KC. A Phase 2 Study of Pembrolizumab Combined with Chemoradiotherapy as Initial Treatment for Anaplastic Thyroid Cancer. Thyroid. 2019 Nov;29(11):1615-1622. doi: 10.1089/thy.2019.0086.
PubMed 31595822Pezzi TA, Mohamed ASR, Sheu T, Blanchard P, Sandulache VC, Lai SY, Cabanillas ME, Williams MD, Pezzi CM, Lu C, Garden AS, Morrison WH, Rosenthal DI, Fuller CD, Gunn GB. Radiation therapy dose is associated with improved survival for unresected anaplastic thyroid carcinoma: Outcomes from the National Cancer Data Base. Cancer. 2017 May 1;123(9):1653-1661. doi: 10.1002/cncr.30493. Epub 2016 Dec 27.
PubMed 28026871Topalian SL, Hodi FS, Brahmer JR, Gettinger SN, Smith DC, McDermott DF, Powderly JD, Carvajal RD, Sosman JA, Atkins MB, Leming PD, Spigel DR, Antonia SJ, Horn L, Drake CG, Pardoll DM, Chen L, Sharfman WH, Anders RA, Taube JM, McMiller TL, Xu H, Korman AJ, Jure-Kunkel M, Agrawal S, McDonald D, Kollia GD, Gupta A, Wigginton JM, Sznol M. Safety, activity, and immune correlates of anti-PD-1 antibody in cancer. N Engl J Med. 2012 Jun 28;366(26):2443-54. doi: 10.1056/NEJMoa1200690. Epub 2012 Jun 2.
PubMed 22658127Chintakuntlawar AV, Rumilla KM, Smith CY, Jenkins SM, Foote RL, Kasperbauer JL, Morris JC, Ryder M, Alsidawi S, Hilger C, Bible KC. Expression of PD-1 and PD-L1 in Anaplastic Thyroid Cancer Patients Treated With Multimodal Therapy: Results From a Retrospective Study. J Clin Endocrinol Metab. 2017 Jun 1;102(6):1943-1950. doi: 10.1210/jc.2016-3756.
PubMed 28324060Lorusso L, Pieruzzi L, Biagini A, Sabini E, Valerio L, Giani C, Passannanti P, Pontillo-Contillo B, Battaglia V, Mazzeo S, Molinaro E, Elisei R. Lenvatinib and other tyrosine kinase inhibitors for the treatment of radioiodine refractory, advanced, and progressive thyroid cancer. Onco Targets Ther. 2016 Oct 20;9:6467-6477. doi: 10.2147/OTT.S84625. eCollection 2016.
PubMed 27799794Sun Y, Niu W, Du F, Du C, Li S, Wang J, Li L, Wang F, Hao Y, Li C, Chi Y. Safety, pharmacokinetics, and antitumor properties of anlotinib, an oral multi-target tyrosine kinase inhibitor, in patients with advanced refractory solid tumors. J Hematol Oncol. 2016 Oct 4;9(1):105. doi: 10.1186/s13045-016-0332-8.
PubMed 27716285Ruan X, Shi X, Dong Q, Yu Y, Hou X, Song X, Wei X, Chen L, Gao M. Antitumor effects of anlotinib in thyroid cancer. Endocr Relat Cancer. 2019 Jan 1;26(1):153-164. doi: 10.1530/ERC-17-0558.
PubMed 30139768Gunda V, Gigliotti B, Ashry T, Ndishabandi D, McCarthy M, Zhou Z, Amin S, Lee KE, Stork T, Wirth L, Freeman GJ, Alessandrini A, Parangi S. Anti-PD-1/PD-L1 therapy augments lenvatinib's efficacy by favorably altering the immune microenvironment of murine anaplastic thyroid cancer. Int J Cancer. 2019 May 1;144(9):2266-2278. doi: 10.1002/ijc.32041. Epub 2019 Jan 24.
PubMed 30515783Golden EB, Apetoh L. Radiotherapy and immunogenic cell death. Semin Radiat Oncol. 2015 Jan;25(1):11-7. doi: 10.1016/j.semradonc.2014.07.005.
PubMed 25481261
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of the Efficacy and Safety of PD-1 Inhibitor and Anlotinib Combined With Multimodal Radiotherapy in the Second-line Treatment of Recurrent or Metastatic Anaplastic Thyroid Cancer
- ClinicalTrials.gov ID
- NCT05659186
- Acronym / sponsor ID
- ChiCTR2100054455
- Conditions
- Thyroid Cancer
- Keywords
- Thyroid Cancer, Immunotherapy, Radiotherapy, Anlotinib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 30 Dec 2022 (estimated)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 21 Dec 2022 (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.
The purpose of this study is to evaluate the efficacy and safety of PD-1 inhibitor and anlotinib combined with multimodal radiotherapy for the second-line treatment of recurrent or metastatic anaplastic thyroid cancer.
Detailed description
Thyroid cancer (TC) is the most common malignant tumor of the endocrine system. It is more common in women and accounts for approximately 4% of all new malignancies in women. TC can be classified according to its pathological type: papillary carcinoma, follicular carcinoma, Hurthle cell carcinoma, medullary carcinoma, and anaplastic thyroid carcinoma (ATC). ATC is more aggressive than other types and tends to metastasize at an early stage. Although ATC accounts for only 1.6%-4% of all TC, the mortality rate is 14%-40%. According to the American Joint Committee on Cancer (AJCC) staging criteria, all ATC is considered stage IV once diagnosed, regardless of the size of the primary site or lymph node metastasis. Until now, the best treatment options for ATC have been unclear, and currently, a combination of treatment options is used. However, the efficiency of treatment is less than 15% and most patients experience recurrence and distant metastases. There is an urgent need for safe and effective treatment options for patients with ATC.
Radiotherapy, as one of the important local treatments, can reduce the tumor load and alleviate local symptoms. Several studies have demonstrated that radiotherapy can improve the prognosis of patients with ATC. The results of a meta-analysis covering 17 studies with a total of 1147 patients showed that postoperative radiotherapy improved the prognosis of patients with ATC compared to those who underwent surgery only. Meanwhile, the results of another large retrospective study showed that radiotherapy resulted in sustained local progression-free survival and overall survival in the treatment of patients with locally advanced ATC and that a radiotherapy dose of ≥60 Gy was an independent prognostic factor (p=0.01). The prognostic role of radiotherapy and different radiotherapy doses was also confirmed in another meta-analysis from the National Cancer Database (NCDB), which showed that patients with inoperable ATC may benefit from radiotherapy at higher irradiation doses (60-70 Gy vs 45-59.9 Gy). It can thus be seen that both operable and inoperable ATC patients, may benefit from radiotherapy and that the dose of radiotherapy may correlate with their survival benefit.
For the systemic treatment of patients with ATC, the NCCN guidelines recommend first-line regimens including paclitaxel combined with carboplatin, doxorubicin combined with doxorubicin, single-agent paclitaxel and single-agent doxorubicin, but patients with ATC respond poorly to treatment and there is no recommended optimal regimen for patients who develop recurrence or metastasis after first-line therapy. In recent years, PD-1/PD-L1 has been used in melanoma and a variety of other solid tumors have demonstrated promising efficacy. The results of a retrospective study in 2017 showed positive PD-1 expression in all specimens of the 16 ATC patients observed, while almost all patients (13/16) were positive for PD-L1 expression. In vitro experiments have also shown that PD-1 blockers can reinvigorate the cytotoxic effects of NK cells, thereby enhancing the killing effect on tumor cells. This lays the theoretical foundation for the use of PD-1/PD-L1 blockers in the treatment of ATC. Multi-target tyrosine kinase inhibitors have shown significant anti-tumor effects in a variety of tumor types, including thyroid cancer, by inhibiting angiogenic and proliferative signaling. Anrotinib is a small molecule multi-target complex kinase inhibitor developed in China and has been reported to be safe and effective in the treatment of patients with advanced refractory solid tumors. In addition to this, the anti-tumor activity of anrotinib in ATC has been In vivo and in vitro assays have demonstrated that anlotinib inhibits ATC cell proliferation and inhibits the migration of thyroid cancer cells in vitro and the growth of xenograft thyroid tumors in mice.
The findings suggest that there may be synergy between PD-1/PD-L1 blockers and complex kinase inhibitors and that PD-1/PD-L1 blockers may improve the tumor microenvironment in ATC, thereby increasing the efficacy of complex kinase inhibitors. This suggests that the combination of PD-1/PD-L1 blockers and complex kinase inhibitors may be an effective treatment option for ATC and that PD-1/PD-L1 blockers may improve resistance to complex kinase inhibitor therapy. PD-L1 blockers may improve the resistance that occurs with complex kinase inhibitor therapy. Meanwhile, the combination of PD-1/PD-L1 blockers with radiotherapy has been shown to have a synergistic effect in several studies. Radiotherapy combined with immunotherapy can activate specific T-cell immune responses and alter the suppressive effect of the tumor microenvironment on the immune system, resulting in durable anti-tumor activity. Combining radiotherapy with PD-1/PD-L1 blockers for the treatment of undifferentiated thyroid cancer may demonstrate better therapeutic outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Cohort | Experimental | Drug: Tislelizumab, Drug: Anlotinib, Radiation: RadiotherapyTislelizumab administration on day 1, and Anlotinib continuous administration from days 1 to 14， every three weeks Radiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Age 18 years or above.
- Patients with pathologically confirmed Undifferentiated thyroid carcinoma and meet the following conditions:
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
- Expected life is greater than or equal to 12 weeks.
- There is at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Key exclusion criteria (19 listed)
- Existing tumor-related hemorrhage。
- History of other malignancies (except for the history of malignant tumors that have been cured and have not recurred within 5 years, such as skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, in situ cervical cancer, and gastrointestinal mucosal cancer, etc.）
- Have an active autoimmune disease requiring systemic treatment or a documented history of clinically severe autoimmune disease.
- Any history of allergic disease, severe hypersensitivity reaction to drugs, or allergy to the study drug components.
- Any prior therapy with:
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 |
|---|---|---|
| TislelizumabAlso: BGB-A317200mg IV Q3W | Drug | Treatment Cohort |
| AnlotinibAlso: AL381812mg PO QD | Drug | Treatment Cohort |
| RadiotherapyMultimodal Radiotherapy | Radiation | Treatment Cohort |
Primary outcome
Objective response rate
Time frame: Up to 60 months
ORR is defined as the percentage of patients who achieve a response, which can either be complete response (complete disappearance of lesions) or partial response (reduction in the sum of maximal tumor diameters by at least 30% or more)
3 secondary outcomes
Progress-Free Survival
Time frame: Up to 60 months
Overall Survival
Time frame: Up to 60 months
Adverse events
Time frame: Up to 60 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2022.
- Background: PubMed 31632557Lin B, Ma H, Ma M, Zhang Z, Sun Z, Hsieh IY, Okenwa O, Guan H, Li J, Lv W. The incidence and survival analysis for anaplastic thyroid cancer: a SEER database analysis. Am J Transl Res. 2019 Sep 15;11(9):5888-5896. eCollection 2019.
- Background: PubMed 31912902Siegel RL, Miller KD, Jemal A. Cancer statistics, 2020. CA Cancer J Clin. 2020 Jan;70(1):7-30. doi: 10.3322/caac.21590. Epub 2020 Jan 8.
- Background: PubMed 30545990Haddad RI, Nasr C, Bischoff L, Busaidy NL, Byrd D, Callender G, Dickson P, Duh QY, Ehya H, Goldner W, Haymart M, Hoh C, Hunt JP, Iagaru A, Kandeel F, Kopp P, Lamonica DM, McIver B, Raeburn CD, Ridge JA, Ringel MD, Scheri RP, Shah JP, Sippel R, Smallridge RC, Sturgeon C, Wang TN, Wirth LJ, Wong RJ, Johnson-Chilla A, Hoffmann KG, Gurski LA. NCCN Guidelines Insights: Thyroid Carcinoma, Version 2.2018. J Natl Compr Canc Netw. 2018 Dec;16(12):1429-1440. doi: 10.6004/jnccn.2018.0089.
- Background: PubMed 24224029Sun C, Li Q, Hu Z, He J, Li C, Li G, Tao X, Yang A. Treatment and prognosis of anaplastic thyroid carcinoma: experience from a single institution in China. PLoS One. 2013 Nov 5;8(11):e80011. doi: 10.1371/journal.pone.0080011. eCollection 2013.
- Background: PubMed 29092098Perrier ND, Brierley JD, Tuttle RM. Differentiated and anaplastic thyroid carcinoma: Major changes in the American Joint Committee on Cancer eighth edition cancer staging manual. CA Cancer J Clin. 2018 Jan;68(1):55-63. doi: 10.3322/caac.21439. Epub 2017 Nov 1.
- Background: PubMed 29072975Subbiah V, Kreitman RJ, Wainberg ZA, Cho JY, Schellens JHM, Soria JC, Wen PY, Zielinski C, Cabanillas ME, Urbanowitz G, Mookerjee B, Wang D, Rangwala F, Keam B. Dabrafenib and Trametinib Treatment in Patients With Locally Advanced or Metastatic BRAF V600-Mutant Anaplastic Thyroid Cancer. J Clin Oncol. 2018 Jan 1;36(1):7-13. doi: 10.1200/JCO.2017.73.6785. Epub 2017 Oct 26.
- Background: PubMed 31595822Chintakuntlawar AV, Yin J, Foote RL, Kasperbauer JL, Rivera M, Asmus E, Garces NI, Janus JR, Liu M, Ma DJ, Moore EJ, Morris JC 3rd, Neben-Wittich M, Price DL, Price KA, Ryder M, Van Abel KM, Hilger C, Samb E, Bible KC. A Phase 2 Study of Pembrolizumab Combined with Chemoradiotherapy as Initial Treatment for Anaplastic Thyroid Cancer. Thyroid. 2019 Nov;29(11):1615-1622. doi: 10.1089/thy.2019.0086.
- Background: PubMed 28026871Pezzi TA, Mohamed ASR, Sheu T, Blanchard P, Sandulache VC, Lai SY, Cabanillas ME, Williams MD, Pezzi CM, Lu C, Garden AS, Morrison WH, Rosenthal DI, Fuller CD, Gunn GB. Radiation therapy dose is associated with improved survival for unresected anaplastic thyroid carcinoma: Outcomes from the National Cancer Data Base. Cancer. 2017 May 1;123(9):1653-1661. doi: 10.1002/cncr.30493. Epub 2016 Dec 27.
- Background: PubMed 22658127Topalian SL, Hodi FS, Brahmer JR, Gettinger SN, Smith DC, McDermott DF, Powderly JD, Carvajal RD, Sosman JA, Atkins MB, Leming PD, Spigel DR, Antonia SJ, Horn L, Drake CG, Pardoll DM, Chen L, Sharfman WH, Anders RA, Taube JM, McMiller TL, Xu H, Korman AJ, Jure-Kunkel M, Agrawal S, McDonald D, Kollia GD, Gupta A, Wigginton JM, Sznol M. Safety, activity, and immune correlates of anti-PD-1 antibody in cancer. N Engl J Med. 2012 Jun 28;366(26):2443-54. doi: 10.1056/NEJMoa1200690. Epub 2012 Jun 2.
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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.
Xingchen Peng, Professor principal investigator
West China Hospital
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 Tislelizumab, Anlotinib and Radiotherapy in people with Thyroid Cancer, run by West China Hospital 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 19 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 21 Dec 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xingchen Peng, Professor (+86 18980606753, pxx2014@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (time frame: Up to 60 months). 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 NCT05659186, which also lists 15 linked publications.
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 Dec 2022.