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Colorectal NeoplasmsPhase 2NCT04911517

Neoadjuvant Chemoradiotherapy Plus Tislelizumab Followed by TME for LARC.

A Phase 2 study testing long course radiotherapy + capecitabine + PD-1 monoclonal antibody treatment combinations in people with Colorectal Neoplasms, run by Beijing Friendship Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Long course radiotherapy plus neoadjuvant chemotherapy followed by resection total mesorecta excision has accepted widespread recognized in the treatment of locally advanced rectal cancer (LARC). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colorectal Neoplasms
What is being tested?
long course radiotherapy + capecitabine + PD-1 monoclonal antibody treatment combinations
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteChina
Study dates
1 Jun 2021to Dec 2024
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

  • Patients have been fully aware of the content of this study and signed the informed consent voluntarily;
  • Patients with rectal cancers must satisfied all the following conditions: Stage II/III LARC (cT1-3N1-2M0)；Tumor distal location ≤10 cm from anal verge (MRI diagnosed);
  • Patients regardless of gender with aged ≥18 years and ECOG score of 0 or 1;
  • Physical and viscera function of patients can withstand major abdominal surgery;
  • Patients are willing and able to follow the study protocol during the study;
  • Patients give consent to the use of blood and pathological specimens for study;
  • Within 28 days prior to enrolment, we must confirm a negative serological pregnancy test for child-bearing age women and they agree to use effective contraception for the duration of drug use and for 60 days after the last dose.

Who cannot join

  • Patients have a present or previous active malignancy except the diagnosis of rectal cancer this time;
  • Patients underwent major surgery within 4 weeks prior to study treatment;
  • Patients have any condition affects the absorption of capecitabine through gastrointestinal tract;
  • Patients have severe uncontrolled recurrent infections, or other severe uncontrolled concomitant diseases;
  • Patients who are allergic to any of the ingredients under study;
  • Patients with severe concomitant diseases with estimated survival ≤ 5 years;
Show all 14Show fewer
  • Patients with present or previous moderate or severe liver and kidney damage presently or previously;
  • Patients have received other study medications or any immunotherapy currently or in the past;
  • Patients preparing for or previously received organ or bone marrow transplant;
  • Patients who received immunosuppressive or systemic hormone therapy for immunosuppressive purposes within 1 month prior to the initiation of study therapy;
  • Patients with congenital or acquired immune deficiency (such as HIV infection);
  • If patients with a history of uncontrolled epilepsy, central nervous system disease or mental disorder, the investigator will determine whether the clinical severity prevents the signing of informed consent or affects the patient's oral medication compliance;
  • Patients with other factors that may affect the study results or cause the study to be terminated midway, such as alcoholism, drug abuse, other serious diseases (including mental illness) requiring combined treatment and severe laboratory examination abnormalities.
  • Pregnant or lactating women

Trial locations and contacts

1 site in 1 country.

Hongwei Yao, Dr. contact

+8613611015609 ext. 63139203

yaohongwei@ccmu.edu.cn

China1 site, 1 recruiting

  • Beijing Friendship Hospital

    Beijing, Beijing Municipality, 100050

    Hongwei Yao, M.D., +8613611015609, yaohongwei@medmail.com.cn

    Recruiting

Other trials in China

About this study

Official title: Rationale and Design of a Prospective, Multicenter Phase Ⅱ Clinical Trial of Safety and Efficacy Evaluation of Long Course Neoadjuvant Chemoradiotherapy Plus Tislelizumab Followed by TME for LARC.

Long course radiotherapy plus neoadjuvant chemotherapy followed by resection total mesorecta excision has accepted widespread recognized in the treatment of locally advanced rectal cancer (LARC). Tislelizumab, an anti-PD1(programmed death 1) humanized IgG4 (Immunoglomin G4) monoclonal antibody, has been demonstrated with clinical activity and is approved for treating recurrent/refractory classical Hodgkin lymphoma and locally advanced/metastatic urothelial carcinoma in China.

The aim of This NCRT-PD-1-LARC trial is to evaluate the efficacy and safety of long course neoadjuvant chemoradiotherapy plus tislelizumab followed by total mesorecta excision for LARC. This NCRT-PD-1-LARC trial will be a prospective, multicenter and phase Ⅱ clinical trial designed to evaluate the safety and efficacy of LARC patients treated with long course neoadjuvant chemoradiotherapy plus tislelizumab followed by total mesorecta excision. It will consecutively enroll 50 stage II/III LARC patients (cT3N0M0 and cT1-3N1-2M0) with the tumor distal location ≤ 10cm from anal verge at 7 centers in China. The enrolled patients will receive long course radiotherapy (50 Gy/25 f, 2 Gy/f, 5 days/week) and three 21-day cycles capecitabine (1000 mg/m2, bid, po, day1-14) plus three 21-day cycles tislelizumab (200 mg, iv.gtt, day8), followed by total mesorecta excision 6-12 week after the end of radiotherapy. The primary efficacy endpoint will be the pathological complete response (pCR) rate, which is defined as absence of viable tumor cells in the primary tumor and lymph nodes.

Being tested
long course radiotherapy + capecitabine + PD-1 monoclonal antibody treatment combinations
Keywords
Colorectal Neoplasms, Programmed Cell Death 1 Receptor, Neoadjuvant Therapy
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • long course radiotherapy + capecitabine + PD-1 monoclonal antibody treatment combinationsCombination product

    long course radiotherapy + capecitabine + PD-1 monoclonal antibody treatment combinations in patients with locally advanced rectal cancer

Study groups in NCT04911517
Study groupRoleWhat they receive
long course radiotherapy + capecitabine + PD-1 monoclonal antibody treatment combinationsExperimentallong course radiotherapy + capecitabine + PD-1 monoclonal antibody treatment combinations in patients with locally advanced rectal cancer
Receives: Combination Product: long course radiotherapy + capecitabine + PD-1 monoclonal antibody treatment combinations

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. pathologic complete response（pCR）

    All the enrolled patients will receive total mesorectal excision (TME) 7-9 weeks after the end of long course radiotherapy. The rectal specimens will be evaluated by the pathologists who are experienced on the rectal cancer diagnosis according to the 1997 Dworak grading system. The rectal cancer will be classified into 5 grades. Grade 0-3 will be considered as non-pCR while grade 4 represent pCR.

    Measured: 1 year

Secondary outcomes (7)

  1. neoadjuvant rectal (NAR) score

    The neoadjuvant rectal (NAR) score is a promising indicator of survival after preoperative chemoradiotherapy for rectal cancer. The NAR score was calculated according to the following formula: NAR score = [5pN - 3(cT - pT) + 12]2∕9.61. (clinical tumor (cT) stage, pathologic tumor (pT) stage, pathologic nodal (pN) stage)

    Measured: 1 year

  2. objective response rate (ORR)

    ORR is evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. The ORR rate is the sum of complete response (CR) and partial response (PR)

    Measured: 1 year

  3. R0 resection rate

    During the surgical process, the surgeon will evaluate the level of cancer resection. It will be classified as R0, R1, R2 resection. Therefore, we can calculate R0 resection rate.

    Measured: 1 year

  4. anal preservation rate

    the surgeon will decide whether the anal can be preserved on the basis of the rectal cancer and intraoperative situation. anal preservation rate is the percentage of patients who achieve anal preservation.

    Measured: 1 year

  5. 3-year local recurrence rate (LRR)

    During the 3-year follow-up, the percentage of local recurrence.

    Measured: 3 year

  6. 3-year disease free survival (DFS)

    During the 3-year follow-up, the percentage of the patients who is disease free.

    Measured: 3 year

  7. 3-year overall survival (OS)

    During the 3-year follow-up, the percentage of the patients who is sill survival at the end of follow-up.

    Measured: 3 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jun 2021
  2. Study start1 Jun 2021
  3. Primary completionDec 2022 (estimated)
  4. Study completionDec 2024 (estimated)

Resources

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
Model description
The enrolled patients in this NCRT-PD-1-LARC trial will receive long course radiotherapy (50 Gy/25 f, 2 Gy/f, 5 days/week) and three 21-day cycles capecitabine (1000 mg/m2, bid, po, day1-14) plus three 21-day cycles tislelizumab (200 mg, iv.gtt, day8), followed by total mesorecta excision 6-8 week after the end of radiotherapy.
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04911517
Sponsor's protocol ID
BFH-NCRTPD
Status last verified
Feb 2022
First submitted
23 May 2021
Last updated
23 Feb 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • Bosset JF, Calais G, Mineur L, Maingon P, Radosevic-Jelic L, Daban A, Bardet E, Beny A, Briffaux A, Collette L. Enhanced tumorocidal effect of chemotherapy with preoperative radiotherapy for rectal cancer: preliminary results--EORTC 22921. J Clin Oncol. 2005 Aug 20;23(24):5620-7. doi: 10.1200/JCO.2005.02.113. Epub 2005 Jul 11.

    PubMed 16009958

  • Gerard JP, Conroy T, Bonnetain F, Bouche O, Chapet O, Closon-Dejardin MT, Untereiner M, Leduc B, Francois E, Maurel J, Seitz JF, Buecher B, Mackiewicz R, Ducreux M, Bedenne L. Preoperative radiotherapy with or without concurrent fluorouracil and leucovorin in T3-4 rectal cancers: results of FFCD 9203. J Clin Oncol. 2006 Oct 1;24(28):4620-5. doi: 10.1200/JCO.2006.06.7629.

    PubMed 17008704

  • Hata T, Takahashi H, Sakai D, Haraguchi N, Nishimura J, Kudo T, Chu M, Takemasa I, Taroh S, Mizushima T, Doki Y, Mori M. Neoadjuvant CapeOx therapy followed by sphincter-preserving surgery for lower rectal cancer. Surg Today. 2017 Nov;47(11):1372-1377. doi: 10.1007/s00595-017-1527-5. Epub 2017 May 4.

    PubMed 28474202

  • Shamseddine A, Zeidan YH, El Husseini Z, Kreidieh M, Al Darazi M, Turfa R, Kattan J, Khalifeh I, Mukherji D, Temraz S, Alqasem K, Amarin R, Al Awabdeh T, Deeba S, Jamali F, Mohamad I, Elkhaldi M, Daoud F, Al Masri M, Dabous A, Hushki A, Jaber O, Charafeddine M, Geara F. Efficacy and safety-in analysis of short-course radiation followed by mFOLFOX-6 plus avelumab for locally advanced rectal adenocarcinoma. Radiat Oncol. 2020 Oct 7;15(1):233. doi: 10.1186/s13014-020-01673-6.

    PubMed 33028346

  • Shen Z, Bu Z, Li A, Lu J, Zhu L, Chong CS, Gao Z, Jiang K, Wang S, Li F, Xiao Y, Ji J, Ye Y. Multicenter study of surgical and oncologic outcomes of extra-levator versus conventional abdominoperineal excision for lower rectal cancer. Eur J Surg Oncol. 2020 Jan;46(1):115-122. doi: 10.1016/j.ejso.2019.08.017. Epub 2019 Aug 21.

    PubMed 31471089

  • Wu F, Zhou C, Wu B, Zhang X, Wang K, Wang J, Xiao L, Wang G. Adding Adjuvants to Fluoropyrimidine-based Neoadjuvant Chemoradiotherapy for Locally Advanced Rectal Cancer: An Option Worthy of Serious Consideration. J Cancer. 2021 Jan 1;12(2):417-427. doi: 10.7150/jca.48337. eCollection 2021.

    PubMed 33391438

  • Chen W, Zheng R, Baade PD, Zhang S, Zeng H, Bray F, Jemal A, Yu XQ, He J. Cancer statistics in China, 2015. CA Cancer J Clin. 2016 Mar-Apr;66(2):115-32. doi: 10.3322/caac.21338. Epub 2016 Jan 25.

    PubMed 26808342

  • Chen WZ, Chen XD, Ma LL, Zhang FM, Lin J, Zhuang CL, Yu Z, Chen XL, Chen XX. Impact of Visceral Obesity and Sarcopenia on Short-Term Outcomes After Colorectal Cancer Surgery. Dig Dis Sci. 2018 Jun;63(6):1620-1630. doi: 10.1007/s10620-018-5019-2. Epub 2018 Mar 16.

    PubMed 29549473

  • Lawler M, Alsina D, Adams RA, Anderson AS, Brown G, Fearnhead NS, Fenwick SW, Halloran SP, Hochhauser D, Hull MA, Koelzer VH, McNair AGK, Monahan KJ, Nathke I, Norton C, Novelli MR, Steele RJC, Thomas AL, Wilde LM, Wilson RH, Tomlinson I; Bowel Cancer UK Critical Research Gaps in Colorectal Cancer Initiative. Critical research gaps and recommendations to inform research prioritisation for more effective prevention and improved outcomes in colorectal cancer. Gut. 2018 Jan;67(1):179-193. doi: 10.1136/gutjnl-2017-315333.

    PubMed 29233930

  • Sung JJY, Chiu HM, Jung KW, Jun JK, Sekiguchi M, Matsuda T, Kyaw MH. Increasing Trend in Young-Onset Colorectal Cancer in Asia: More Cancers in Men and More Rectal Cancers. Am J Gastroenterol. 2019 Feb;114(2):322-329. doi: 10.14309/ajg.0000000000000133.

    PubMed 30694865

  • Cao Y, Li W, Wang Z, Pang H. Potential and unsolved problems of anti-PD-1/PD-L1 therapy combined with radiotherapy. Tumori. 2021 Aug;107(4):282-291. doi: 10.1177/0300891620940382. Epub 2020 Jul 31.

    PubMed 32734832

  • Yang Z, Ma J, Han J, Li A, Liu G, Sun Y, Zheng J, Zhang J, Chen G, Xu R, Sun L, Meng C, Gao J, Bai Z, Deng W, Zhang C, Su J, Yao H, Zhang Z. Gut microbiome model predicts response to neoadjuvant immunotherapy plus chemoradiotherapy in rectal cancer. Med. 2024 Oct 11;5(10):1293-1306.e4. doi: 10.1016/j.medj.2024.07.002. Epub 2024 Jul 23.

    PubMed 39047732

  • Gao J, Zhang X, Yang Z, Zhang J, Bai Z, Deng W, Chen G, Xu R, Wei Q, Liu Y, Han J, Li A, Liu G, Sun Y, Kong D, Yao H, Zhang Z. Interim result of phase II, prospective, single-arm trial of long-course chemoradiotherapy combined with concurrent tislelizumab in locally advanced rectal cancer. Front Oncol. 2023 Feb 2;13:1057947. doi: 10.3389/fonc.2023.1057947. eCollection 2023.

    PubMed 36816939

  • Yang Z, Zhang X, Zhang J, Gao J, Bai Z, Deng W, Chen G, An Y, Liu Y, Wei Q, Han J, Li A, Liu G, Sun Y, Kong D, Yao H, Zhang Z. Rationale and design of a prospective, multicenter, phase II clinical trial of safety and efficacy evaluation of long course neoadjuvant chemoradiotherapy plus tislelizumab followed by total mesorectal excision for locally advanced rectal cancer (NCRT-PD1-LARC trial). BMC Cancer. 2022 Apr 27;22(1):462. doi: 10.1186/s12885-022-09554-9.

    PubMed 35477432

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing long course radiotherapy + capecitabine + PD-1 monoclonal antibody treatment combinations in people with Colorectal Neoplasms, run by Beijing Friendship 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 7 inclusion and 14 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 23 Feb 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 Hongwei Yao, Dr. (+8613611015609 ext. 63139203, yaohongwei@ccmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

pathologic complete response（pCR） (time frame: 1 year). 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 NCT04911517, which also lists 14 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 23 Feb 2022.

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