NCT07622667

Brief Summary

This study is a single-center observational investigation aimed at systematically exploring the key molecular features influencing the prognosis of malignant tumors by integrating multidimensional clinical information with multi-omics molecular data. The goal is to provide a critical scientific basis for constructing precise prognostic prediction models, identifying potential therapeutic targets, and optimizing clinical treatment strategies. The study plans to consecutively enroll adult patients with histologically confirmed malignant tumors who received antitumor therapy at our hospital between January 2017 and December 2025. Clinical data (including demographic characteristics, tumor pathology information, treatment histories, and survival follow-up data) will be systematically collected from electronic medical records. Additionally, tumor tissue or blood samples will be obtained from the patients for sequencing, staining, ELISA, drug sensitivity testing, and flow cytometry analysis to comprehensively characterize the genomic features, immune microenvironment, and cellular heterogeneity of the tumors.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
12mo left

Started May 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress4%
May 2026Jun 2027

First Submitted

Initial submission to the registry

May 28, 2026

Completed
1 day until next milestone

Study Start

First participant enrolled

May 29, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 3, 2026

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2027

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2027

Last Updated

June 3, 2026

Status Verified

May 1, 2026

Enrollment Period

8 months

First QC Date

May 28, 2026

Last Update Submit

May 28, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Overall Survival (OS)

    The time from the start of treatment to death from any cause. Patients who are alive at the last follow-up are censored.

    From date of treatment initiation until date of death or last follow-up, assessed up to 5 years.

Secondary Outcomes (3)

  • Progression-Free Survival (PFS)

    From date of treatment initiation until date of progression or death, assessed up to 5 years.

  • Pathological Complete Response (pCR)

    At the time of surgery following neoadjuvant treatment, typically within 4-6 weeks after completion of therapy.

  • Major Pathologic Response (MRP)

    At the time of surgery following neoadjuvant treatment, typically within 4-6 weeks after completion of therapy.

Study Arms (3)

Immunotherapy Group

Drug: Immunotherapy Therapy

Radiotherapy Group

Radiation: Radiation Therapy

Surgery Group

Procedure: Radical surgery

Interventions

Patients receiving immunotherapies such as immune checkpoint inhibitors. Immunotherapy can be administered as first-line or subsequent treatment, or as part of combination therapy, integrated with modalities such as surgery, chemotherapy, radiotherapy, and targeted therapy.

Immunotherapy Group

Patients for whom radiotherapy is the primary or a significant component of their treatment. Radiotherapy may be administered with curative, adjuvant, or palliative intent, and can be given alone or in combination with surgery, chemotherapy, targeted therapy, immunotherapy, etc.

Radiotherapy Group

Patients undergoing curative tumor resection as their primary treatment modality. Surgery may be performed with or without neoadjuvant/adjuvant chemotherapy, radiotherapy, targeted therapy, or immunotherapy.

Surgery Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with pathologically confirmed malignant tumors.

You may qualify if:

  • Voluntarily sign the informed consent form.
  • Treated at Nanfang Hospital, Southern Medical University between January 2017 and December 2025.
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.
  • Availability of surplus routinely discarded clinical tumor tissue samples (biopsy specimens or pathological sections) or blood samples for assays such as sequencing, staining, ELISA, drug sensitivity testing, and flow cytometry.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, China

RECRUITING

Related Publications (10)

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  • Le DT, Durham JN, Smith KN, Wang H, Bartlett BR, Aulakh LK, Lu S, Kemberling H, Wilt C, Luber BS, Wong F, Azad NS, Rucki AA, Laheru D, Donehower R, Zaheer A, Fisher GA, Crocenzi TS, Lee JJ, Greten TF, Duffy AG, Ciombor KK, Eyring AD, Lam BH, Joe A, Kang SP, Holdhoff M, Danilova L, Cope L, Meyer C, Zhou S, Goldberg RM, Armstrong DK, Bever KM, Fader AN, Taube J, Housseau F, Spetzler D, Xiao N, Pardoll DM, Papadopoulos N, Kinzler KW, Eshleman JR, Vogelstein B, Anders RA, Diaz LA Jr. Mismatch repair deficiency predicts response of solid tumors to PD-1 blockade. Science. 2017 Jul 28;357(6349):409-413. doi: 10.1126/science.aan6733. Epub 2017 Jun 8.

    PMID: 28596308BACKGROUND
  • Samstein RM, Lee CH, Shoushtari AN, Hellmann MD, Shen R, Janjigian YY, Barron DA, Zehir A, Jordan EJ, Omuro A, Kaley TJ, Kendall SM, Motzer RJ, Hakimi AA, Voss MH, Russo P, Rosenberg J, Iyer G, Bochner BH, Bajorin DF, Al-Ahmadie HA, Chaft JE, Rudin CM, Riely GJ, Baxi S, Ho AL, Wong RJ, Pfister DG, Wolchok JD, Barker CA, Gutin PH, Brennan CW, Tabar V, Mellinghoff IK, DeAngelis LM, Ariyan CE, Lee N, Tap WD, Gounder MM, D'Angelo SP, Saltz L, Stadler ZK, Scher HI, Baselga J, Razavi P, Klebanoff CA, Yaeger R, Segal NH, Ku GY, DeMatteo RP, Ladanyi M, Rizvi NA, Berger MF, Riaz N, Solit DB, Chan TA, Morris LGT. Tumor mutational load predicts survival after immunotherapy across multiple cancer types. Nat Genet. 2019 Feb;51(2):202-206. doi: 10.1038/s41588-018-0312-8. Epub 2019 Jan 14.

    PMID: 30643254BACKGROUND
  • Mok TSK, Wu YL, Kudaba I, Kowalski DM, Cho BC, Turna HZ, Castro G Jr, Srimuninnimit V, Laktionov KK, Bondarenko I, Kubota K, Lubiniecki GM, Zhang J, Kush D, Lopes G; KEYNOTE-042 Investigators. Pembrolizumab versus chemotherapy for previously untreated, PD-L1-expressing, locally advanced or metastatic non-small-cell lung cancer (KEYNOTE-042): a randomised, open-label, controlled, phase 3 trial. Lancet. 2019 May 4;393(10183):1819-1830. doi: 10.1016/S0140-6736(18)32409-7. Epub 2019 Apr 4.

    PMID: 30955977BACKGROUND
  • Cortazar P, Zhang L, Untch M, Mehta K, Costantino JP, Wolmark N, Bonnefoi H, Cameron D, Gianni L, Valagussa P, Swain SM, Prowell T, Loibl S, Wickerham DL, Bogaerts J, Baselga J, Perou C, Blumenthal G, Blohmer J, Mamounas EP, Bergh J, Semiglazov V, Justice R, Eidtmann H, Paik S, Piccart M, Sridhara R, Fasching PA, Slaets L, Tang S, Gerber B, Geyer CE Jr, Pazdur R, Ditsch N, Rastogi P, Eiermann W, von Minckwitz G. Pathological complete response and long-term clinical benefit in breast cancer: the CTNeoBC pooled analysis. Lancet. 2014 Jul 12;384(9938):164-72. doi: 10.1016/S0140-6736(13)62422-8. Epub 2014 Feb 14.

    PMID: 24529560BACKGROUND
  • Reig M, Sanduzzi-Zamparelli M, Forner A, Rimola J, Ferrer-Fabrega J, Burrel M, Garcia-Criado A, Diaz A, Llarch N, Iserte G, Molla M, Kelley RK, Galle PR, Mazzaferro V, Salem R, Sangro B, Singal AG, Vogel A, Yanagihara TK, Ayuso C, Torres F, Bruix J. BCLC strategy for prognosis prediction and treatment recommendations: The 2026 update. J Hepatol. 2026 Mar;84(3):631-654. doi: 10.1016/j.jhep.2025.10.020. Epub 2025 Oct 27.

    PMID: 41151697BACKGROUND
  • Rami-Porta R, Nishimura KK, Giroux DJ, Detterbeck F, Cardillo G, Edwards JG, Fong KM, Giuliani M, Huang J, Kernstine KH Sr, Marom EM, Nicholson AG, Van Schil PE, Travis WD, Tsao MS, Watanabe SI, Rusch VW, Asamura H; Members of the IASLC Staging and Prognostic Factors Committee and of the Advisory Boards, and Participating Institutions. The International Association for the Study of Lung Cancer Lung Cancer Staging Project: Proposals for Revision of the TNM Stage Groups in the Forthcoming (Ninth) Edition of the TNM Classification for Lung Cancer. J Thorac Oncol. 2024 Jul;19(7):1007-1027. doi: 10.1016/j.jtho.2024.02.011. Epub 2024 Mar 4.

    PMID: 38447919BACKGROUND
  • GBD 2023 Cancer Collaborators. The global, regional, and national burden of cancer, 1990-2023, with forecasts to 2050: a systematic analysis for the Global Burden of Disease Study 2023. Lancet. 2025 Oct 11;406(10512):1565-1586. doi: 10.1016/S0140-6736(25)01635-6. Epub 2025 Sep 24.

    PMID: 41015051BACKGROUND

MeSH Terms

Conditions

Neoplasms

Interventions

Radiotherapy

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Wei Wang Wang

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 28, 2026

First Posted

June 3, 2026

Study Start

May 29, 2026

Primary Completion (Estimated)

January 30, 2027

Study Completion (Estimated)

June 30, 2027

Last Updated

June 3, 2026

Record last verified: 2026-05

Locations