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Preoperative Radiotherapy and Anlotinib With or Without Penpulimab for Soft Tissue Sarcoma (SPARE-04)

21 maggio 2026 aggiornato da: NINGNING LU, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

A Prospective Multicenter Randomized Controlled Study of Preoperative Radiotherapy Combined With Targeted Therapy With or Without Immunotherapy for Soft Tissue Sarcoma

Soft tissue sarcoma is a rare cancer that often requires surgery combined with radiotherapy. Preoperative radiotherapy can improve the chance of complete tumor removal and limb preservation, but some patients still experience local recurrence, distant metastasis, or poor tumor response.

This is a prospective, multicenter, randomized phase II study for patients with localized soft tissue sarcoma of the extremity or trunk who need preoperative radiotherapy. Participants will be randomly assigned to receive preoperative radiotherapy plus anlotinib, or preoperative radiotherapy plus anlotinib and penpulimab. Surgery will be performed after completion of neoadjuvant treatment according to the study protocol.

The main purpose of this study is to evaluate whether adding penpulimab to preoperative radiotherapy and anlotinib can improve 3-year disease-free survival. The study will also assess pathological response, wound complications, treatment-related adverse events, local control, distant metastasis-free survival, overall survival, limb function, quality of life, and exploratory biomarkers related to treatment response.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Preoperative radiotherapy is an established treatment approach for patients with localized soft tissue sarcoma of the extremity or trunk, particularly when limb preservation and complete surgical resection are important treatment goals. However, the pathological response to preoperative radiotherapy alone remains limited in some patients, and local recurrence or distant metastasis can still occur after multidisciplinary treatment.

Anlotinib is a multitarget tyrosine kinase inhibitor with antiangiogenic activity and has shown clinical activity in soft tissue sarcoma. Immune checkpoint blockade may further enhance antitumor effects when combined with radiotherapy and antiangiogenic therapy by modulating the tumor microenvironment. The optimal patient population and risk-benefit profile of this combined neoadjuvant strategy require prospective evaluation.

This study is designed to compare preoperative radiotherapy plus anlotinib with preoperative radiotherapy plus anlotinib and penpulimab in patients with localized soft tissue sarcoma who are candidates for neoadjuvant treatment followed by surgery. The study will evaluate whether the addition of penpulimab improves disease control while maintaining acceptable safety, surgical feasibility, and postoperative wound healing.

Participants will receive protocol-defined neoadjuvant treatment before surgery and will be followed after surgery for disease outcomes, safety, limb function, quality of life, and translational biomarker analyses. The study also includes collection and analysis of clinical, imaging, pathological, and molecular data to explore potential predictors of treatment response and resistance.

Tipo di studio

Interventistico

Iscrizione (Stimato)

274

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

  • Cina
    • Beijing Municipality
      • Beijing, Beijing Municipality, Cina, 100021
        • Cancer Hospital, National Cancer Center, CAMS & PUMC

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Bambino
  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

Inclusion Criteria:

  • Primary or recurrent soft tissue sarcoma of the extremity or trunk with intermediate- to high-grade disease and tumor size >=5 cm or deep-seated tumor, for which radiotherapy is recommended after multidisciplinary evaluation.
  • Age >=15 years.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 3.
  • Histologically confirmed soft tissue sarcoma.
  • At least one evaluable lesion.
  • Able to tolerate radiotherapy, anlotinib, and penpulimab treatment.
  • Female participants of childbearing potential, or male participants with female partners of childbearing potential, must agree to use effective contraception during the treatment period and for 6 months after the last dose of study treatment.
  • Able to provide written informed consent.
  • Able and willing to comply with follow-up.

Exclusion Criteria:

  • No gross tumor remaining after unplanned tumor resection performed at another hospital.
  • Contraindications to targeted therapy or immunotherapy due to comorbidities, including allergy, autoimmune disease, active bleeding, ulcer, intestinal perforation, intestinal obstruction, uncontrolled hypertension, New York Heart Association class III-IV cardiac dysfunction, or severe hepatic or renal dysfunction.
  • Dermatofibrosarcoma protuberans, desmoid fibromatosis, tenosynovial giant cell tumor, or other locally aggressive diseases.
  • Benign tumors.
  • Sarcoma subtypes for which chemotherapy is recommended as the preferred neoadjuvant treatment according to guidelines, such as embryonal rhabdomyosarcoma or Ewing sarcoma.
  • Lipoma-like liposarcoma or well-differentiated liposarcoma.
  • New malignant tumor within 5 years before enrollment, except cervical carcinoma in situ, early-stage basal cell carcinoma of the skin, or early-stage lung cancer.
  • Soft tissue sarcoma that can be cured by wide local excision alone.
  • Prior radiotherapy to the same anatomical site.
  • Other severe medical comorbidities that would preclude surgery or participation in this study.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: Arm A: Preoperative Radiotherapy Plus Anlotinib
Preoperative Radiotherapy Plus Anlotinib
Droga: Anlotinib
Anlotinib will be administered orally at 12 mg once daily, starting 1 week before radiotherapy and continuing until 4 weeks after completion of radiotherapy, on a 2-weeks-on and 1-week-off schedule for 3 cycles. Dose modification will be performed according to protocol-defined toxicity management criteria.
Radiazione: Preoperative Radiotherapy
Preoperative radiotherapy will be delivered according to the protocol-defined target volume and dose schedule before surgery. Radiotherapy may be given as conventional fractionation or moderate hypofractionation according to the study protocol.
Altri nomi:
  • Radioterapia neoadiuvante
Procedura: Surgery
Surgery will be performed after completion of neoadjuvant treatment. The goal of surgery is complete tumor resection while preserving organ and limb function whenever feasible, according to protocol-defined surgical principles.
Sperimentale: Arm B: Preoperative Radiotherapy Plus Anlotinib and Penpulimab
Preoperative Radiotherapy Plus Anlotinib and Penpulimab
Droga: Anlotinib
Anlotinib will be administered orally at 12 mg once daily, starting 1 week before radiotherapy and continuing until 4 weeks after completion of radiotherapy, on a 2-weeks-on and 1-week-off schedule for 3 cycles. Dose modification will be performed according to protocol-defined toxicity management criteria.
Radiazione: Preoperative Radiotherapy
Preoperative radiotherapy will be delivered according to the protocol-defined target volume and dose schedule before surgery. Radiotherapy may be given as conventional fractionation or moderate hypofractionation according to the study protocol.
Altri nomi:
  • Radioterapia neoadiuvante
Procedura: Surgery
Surgery will be performed after completion of neoadjuvant treatment. The goal of surgery is complete tumor resection while preserving organ and limb function whenever feasible, according to protocol-defined surgical principles.
Droga: Penpulimab
Penpulimab will be administered intravenously at 200 mg every 3 weeks, starting 1 week before radiotherapy and continuing until 4 weeks after completion of radiotherapy, for a total of 3 cycles.
Altri nomi:
  • Anticorpo anti-PD-1

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
3-Year Disease-Free Survival
Lasso di tempo: From randomization to 3 years after randomization
Disease-free survival is defined as the time from randomization to the first occurrence of local recurrence, distant metastasis, new malignancy, or death from any cause. Participants without an event will be censored at the date of last follow-up.
From randomization to 3 years after randomization

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Investigatori

  • Investigatore principale: Ning-Ning Lu, Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 luglio 2026

Completamento primario (Stimato)

31 dicembre 2031

Completamento dello studio (Stimato)

31 dicembre 2031

Date di iscrizione allo studio

Primo inviato

21 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

21 maggio 2026

Primo Inserito (Effettivo)

28 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

28 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

21 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • NCC6371

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

INDECISO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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